Recall archive / FDA device enforcement

Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, P... — FDA record Z-2992-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Classification: Class II
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: Not supplied
Agency-reported status: Ongoing
Source record identifier: Z-2992-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	00-398281J , Lot Number 19FBL693 ; 00-398281J , Lot Number 19HBQ768 ; 00-398281J , Lot Number 19IBJ984 ; 00-398281J , Lot Number 19JBM853 ; 00-398650AG, Lot Number 19ABM946 ; 00-398650AG, Lot Number 19BBS748 ; 00-398650AG, Lot Number 19CBJ825 ; 00-398650AG, Lot Number 19DBR708 ; 00-398650AG, Lot Number 19FBR243 ; 00-398650AG, Lot Number 19IBV635 ; 00-398650AG, Lot Number 19KBL462 ; 00-398650AG, Lot Number 20MBA140 ; 00-398650AG, Lot Number 20EBE408 ; 00-398650AG, Lot Number 20FBJ771 ; 00-398650AG, Lot Number 20HBI575 ; 00-398650AG, Lot Number 20JBJ100 ; 00-398650AG, Lot Number 21ABP363 ; 00-398650AG, Lot Number 21ABQ027 ; 00-398650AI, Lot Number 21FBT441 ; 00-398650AI, Lot Number 21IBH355 ; 00-398650AI, Lot Number 21KBM869 ; 00-398650AI, Lot Number 21LBH937 ; 00-398650AI, Lot Number 22BBA596 ; 00-398650AI, Lot Number 22CBY494 ; 00-398650AI, Lot Number 22DBQ496 ; 00-398650AI, Lot Number 22FBL546 ; 00-398650AI, Lot Number 22GBJ321 ; 00-398650AI, Lot Number 22JBE607 ; 00-398650AI, Lot Number 22JBE609 ; 00-398650AI, Lot Number 21EBB527 ; 00-398712S , Lot Number 19KMA101 ; 00-398712S , Lot Number 19LMB722 ; 00-398712S , Lot Number 20CMA260 ; 00-398712S , Lot Number 20CMC911 ; 00-398712S , Lot Number 20FMA921 ; 00-398712S , Lot Number 20GMB435 ; 00-398712S , Lot Number 20IMA653 ; 00-398712S , Lot Number 20KMA809 ; 00-398712S , Lot Number 20LMD895 ; 00-398712S , Lot Number 21CMD722 ; 00-398712S , Lot Number 21EMF323 ; 00-398712S , Lot Number 21HMB142 ; 00-398712S , Lot Number 21IMB825 ; 00-398712S , Lot Number 21JMH910 ; 00-398712S , Lot Number 21LMG148 ; 00-398712S , Lot Number 22BMH320 ; 00-398712S , Lot Number 22DME594 ; 00-398712S , Lot Number 22HMI166 ; 00-398712S , Lot Number 22JME059 ; 00-398712S , Lot Number 23AME236 ; 00-398712S , Lot Number 23DME416 ; 00-398712S , Lot Number 23FMG905 ; 00-398712S , Lot Number 23IMF984 ; 00-398712S , Lot Number 23KMF990 ; 00-398712S , Lot Number 19BKB212 ; 00-398712S , Lot Number 19CKB198 ; 00-398712S , Lot Number 19EKB257 ; 00-398712S , Lot Number 19GKC485 ; 00-398712S , Lot Number 19IKA568 ; 00-398712S , Lot Number 19IKB991 ; 00-398725AM, Lot Number 21FBJ550 ; 00-398725AM, Lot Number 19IBJ529 ; 00-398725AM, Lot Number 19KBS571 ; 00-398725AM, Lot Number 19KBU397 ; 00-398725AM, Lot Number 20BBE698 ; 00-398725AM, Lot Number 20CBG353 ; 00-398725AM, Lot Number 20DBI198 ; 00-398725AM, Lot Number 20FBB296 ; 00-398725AM, Lot Number 20FBC302 ; 00-398725AM, Lot Number 20GBF723 ; 00-398725AM, Lot Number 20HBM698 ; 00-398725AM, Lot Number 20LBR908 ; 00-398725AM, Lot Number 21BBE202 ; 00-398725AM, Lot Number 21DBD638 ; 00-399360K , Lot Number 21VBC685 ; 00-399360K , Lot Number 23FBU384 ; 00-399360K , Lot Number 23IBA381 ; 00-399360K , Lot Number 23KBE043 ; 00-399360K , Lot Number 23LBR853 ; 00-399734N , Lot Number 23JBU818 ; 00-399734N , Lot Number 23KBI990 ; 00-399734N , Lot Number 23LBV170 ; 00-399734N , Lot Number 19ADB519 ; 00-399734N , Lot Number 19BDB357 ; 00-399734N , Lot Number 19DDA161 ; 00-399734N , Lot Number 19EDA281 ; 00-399734N , Lot Number 19EDC270 ; 00-399734N , Lot Number 19GDA275 ; 00-399734N , Lot Number 19IDA132 ; 00-399734N , Lot Number 19LMA267 ; 00-399734N , Lot Number 20BMA475 ; 00-399734N , Lot Number 20DMA774 ; 00-399734N , Lot Number 20GMB326 ; 00-399734N , Lot Number 20IMD767 ; 00-399734N , Lot Number 20JMC215 ; 00-399734N , Lot Number 21DMA867 ; 00-399734N , Lot Number 21DME739 ; 00-399734N , Lot Number 21FMF556 ; 00-399734N , Lot Number 21IMA047 ; 00-399734N , Lot Number 21JME290 ; 00-399734N , Lot Number 21JMH037 ; 00-399734N , Lot Number 22CMF020 ; 00-399734N , Lot Number 22DMF495 ; 00-399734N , Lot Number 22GMB900 ; 00-399734N , Lot Number 22IMA125 ; 00-399734N , Lot Number 22JME374 ; 00-399734N , Lot Number 22LMB989 ; 00-399734N , Lot Number 23DMA849 ; 00-399734N , Lot Number 23EMC285 ; 00-399734N , Lot Number 23EMJ483 ; 00-399983Q , Lot Number 19BBE921 ; 00-399983Q , Lot Number 19CBY031 ; 00-399983Q , Lot Number 19PBC257 ; 00-399983Q , Lot Number 19FBR534 ; 00-399983Q , Lot Number 19HBF178 ; 00-399983Q , Lot Number 19KBF830 ; 00-399983Q , Lot Number 19LBP680 ; 00-399983Q , Lot Number 20ABX119 ; 00-399983Q , Lot Number 20CBX476 ; 00-399983Q , Lot Number 20EMA308 ; 00-399983Q , Lot Number 20GMA221 ; 00-399983Q , Lot Number 20HMD089 ; 00-399983Q , Lot Number 20JMA848 ; 00-399983Q , Lot Number 20JMC961 ; 00-399983Q , Lot Number 21AMB499 ; 00-399983R , Lot Number 21DMF325 ; 00-399983R , Lot Number 21GMD901 ; 00-399983R , Lot Number 21HMA462 ; 00-399983R , Lot Number 21KMF309 ; 00-399983R , Lot Number 21KMH211 ; 00-399983R , Lot Number 21LMA509 ; 00-399983R , Lot Number 22AME571 ; 00-399983R , Lot Number 22EMC467 ; 00-399983R , Lot Number 22HME724 ; 00-399983R , Lot Number 22KMB997 ; 00-399983R , Lot Number 23AMA130 ; 00-399983R , Lot Number 23CMA230 ; 00-400065K , Lot Number 21FBR263 ; 00-400065K , Lot Number 21HBB836 ; 00-400065K , Lot Number 21JBL879 ; 00-400065K , Lot Number 21KBF878 ; 00-400065K , Lot Number 21LBU544 ; 00-400065K , Lot Number 22BBG118 ; 00-400065K , Lot Number 19ABB720 ; 00-400065K , Lot Number 22CBU488 ; 00-400065K , Lot Number 19BBQ915 ; 00-400065K , Lot Number 19CBM065 ; 00-400065K , Lot Number 22DBP187 ; 00-400065K , Lot Number 19DBM042 ; 00-400065K , Lot Number 22EBP317 ; 00-400065K , Lot Number 19EBX671 ; 00-400065K , Lot Number 22HBF260 ; 00-400065K , Lot Number 19GBN148 ; 00-400065K , Lot Number 22KBG632 ; 00-400065K , Lot Number 19JBB584 ; 00-400065K , Lot Number 19JBI267 ; 00-400065K , Lot Number 22LBO309 ; 00-400065K , Lot Number 23ABG526 ; 00-400065K , Lot Number 23BBQ040 ; 00-400065K , Lot Number 19KBY541 ; 00-400065K , Lot Number 23CBJ011 ; 00-400065K , Lot Number 20MBA423 ; 00-400065K , Lot Number 20CBC516 ; 00-400065K , Lot Number 20DBM271 ; 00-400065K , Lot Number 20FBD765 ; 00-400065K , Lot Number 20GBH479 ; 00-400065K , Lot Number 20HBW054 ; 00-400065K , Lot Number 20JBN060 ; 00-400065K , Lot Number 20KBW249 ; 00-400065K , Lot Number 21BBD722 ; 00-400065K , Lot Number 21CBV490 ; 00-400069F , Lot Number 21GBJ540 ; 00-400069F , Lot Number 21HBN535 ; 00-400069F , Lot Number 21JBV864 ; 00-400069F , Lot Number 19KBY112 ; 00-400069F , Lot Number 19KBZ300 ; 00-400069F , Lot Number 19LBT262 ; 00-400069F , Lot Number 20ABA121 ; 00-400069F , Lot Number 20ABE706 ; 00-400069F , Lot Number 20FBH567 ; 00-400069F , Lot Number 20FBU536 ; 00-400069F , Lot Number 20HBM357 ; 00-400069F , Lot Number 20IBI988 ; 00-400069F , Lot Number 20JBE618 ; 00-400069F , Lot Number 20LBM288 ; 00-400069F , Lot Number 20LBM394 ; 00-400069F , Lot Number 20LBR652 ; 00-400069F , Lot Number 21ABB713 ; 00-400069F , Lot Number 21CBR762 ; 00-400123AC, Lot Number 19ABQ452 ; 00-400123AC, Lot Number 19BBN072 ; 00-400123AC, Lot Number 19BBT797 ; 00-400123AC, Lot Number 19CBR393 ; 00-400123AC, Lot Number 19DBP114 ; 00-400123AC, Lot Number 19EBR874 ; 00-400123AC, Lot Number 19EBZ557 ; 00-400123AC, Lot Number 19GBW344 ; 00-400123AC, Lot Number 19VBA449 ; 00-400123AC, Lot Number 19LBE973 ; 00-400123AC, Lot Number 20BBI940 ; 00-400123AC, Lot Number 20CBU720 ; 00-400123AC, Lot Number 20FBC048 ; 00-400123AD, Lot Number 21GBB662 ; 00-400123AD, Lot Number 21HBE405 ; 00-400123AD, Lot Number 21JBT553 ; 00-400123AD, Lot Number 21JBT555 ; 00-400123AD, Lot Number 21LBM691 ; 00-400123AD, Lot Number 22ABN198 ; 00-400123AD, Lot Number 22EBG139 ; 00-400123AD, Lot Number 22GBB778 ; 00-400123AD, Lot Number 20IBL629 ; 00-400123AD, Lot Number 20JBL358 ; 00-400123AD, Lot Number 21ABG411 ; 00-400123AD, Lot Number 21BBD488 ; 00-400123AD, Lot Number 21CBJ466 ; 00-400290D , Lot Number 21JBL730 ; 00-400290D , Lot Number 21JBL760 ; 00-400290D , Lot Number 22BBL397 ; 00-400290D , Lot Number 22DBD105 ; 00-400290D , Lot Number 22HBX245 ; 00-400290D , Lot Number 22IBJ158 ; 00-400290D , Lot Number 23ABM361 ; 00-400290D , Lot Number 23FBB540 ; 00-400290D , Lot Number 23HBW414 ; 00-400290D , Lot Number 23KBQ874 ; 00-400305Q , Lot Number 21FBH829 ; 00-400305Q , Lot Number 19BBI732 ; 00-400305Q , Lot Number 19CBT638 ; 00-400305Q , Lot Number 19FBK838 ; 00-400305Q , Lot Number 19HBQ608 ; 00-400305Q , Lot Number 19JBF448 ; 00-400305Q , Lot Number 19KBK353 ; 00-400305Q , Lot Number 19LBT845 ; 00-400305Q , Lot Number 20CBX252 ; 00-400305Q , Lot Number 20EBB804 ; 00-400305Q , Lot Number 20EBO003 ; 00-400305Q , Lot Number 20FBD660 ; 00-400305Q , Lot Number 20FBK609 ; 00-400305Q , Lot Number 20GBB363 ; 00-400305Q , Lot Number 20GBT691 ; 00-400305Q , Lot Number 20KBN359 ; 00-400305Q , Lot Number 21ABG937 ; 00-400763F , Lot Number 19ABQ264 ; 00-400763F , Lot Number 19CBJ552 ; 00-400763F , Lot Number 19EBI331 ; 00-400763F , Lot Number 19FBK986 ; 00-400763F , Lot Number 20CBL280 ; 00-400763F , Lot Number 20DBV350 ; 00-400763F , Lot Number 20FBI815 ; 00-400763F , Lot Number 20HBD412 ; 00-400763F , Lot Number 20XBG604 ; 00-400763F , Lot Number 21ABL875 ; 00-400763F , Lot Number 21BBC738 ; 00-400863J , Lot Number 22HBU529 ; 00-400863J , Lot Number 23ABJ577 ; 00-400932O , Lot Number 19BBU120 ; 00-400932O , Lot Number 19CBR446 ; 00-400932O , Lot Number 19EBA051 ; 00-400932O , Lot Number 19FBB043 ; 00-401030S , Lot Number 19ABV014 ; 00-401030S , Lot Number 19CBE728 ; 00-401030S , Lot Number 19DBG910 ; 00-401030S , Lot Number 19QBC207 ; 00-401030S , Lot Number 19FBK697 ; 00-401030S , Lot Number 19JBH635 ; 00-401030S , Lot Number 19KBH432 ; 00-401030S , Lot Number 20BBS390 ; 00-401030S , Lot Number 23HBC817 ; 00-401030S , Lot Number 23IBG655 ; 00-401030S , Lot Number 23JBU657 ; 00-401030S , Lot Number 23LBA284 ; 00-401030S , Lot Number 23LBK479 ; 00-401030S , Lot Number 20FMB629 ; 00-401030S , Lot Number 20HMA737 ; 00-401030S , Lot Number 20IMB800 ; 00-401030S , Lot Number 20JMD194 ; 00-401030S , Lot Number 20LMC207 ; 00-401030S , Lot Number 20LME822 ; 00-401030S , Lot Number 21GMC427 ; 00-401030S , Lot Number 21IMA147 ; 00-401030S , Lot Number 21IME724 ; 00-401030S , Lot Number 22AMB985 ; 00-401030S , Lot Number 22AMG093 ; 00-401030S , Lot Number 22BMF120 ; 00-401030S , Lot Number 22EMC963 ; 00-401030S , Lot Number 22FMF626 ; 00-401030S , Lot Number 22IMB853 ; 00-401030S , Lot Number 22JME308 ; 00-401030S , Lot Number 22KMG715 ; 00-401030S , Lot Number 23BMA914 ; 00-401030S , Lot Number 23BME201 ; 00-401030S , Lot Number 23DMB789 ; 00-401030S , Lot Number 23EMC356 ; 00-401030S , Lot Number 23FMB166 ; 00-401178D , Lot Number 21GBC991 ; 00-401178D , Lot Number 21KBI883 ; 00-401178D , Lot Number 21LBM169 ; 00-401178D , Lot Number 22ABX434 ; 00-401178D , Lot Number 19ABG094 ; 00-401178D , Lot Number 22BBW843 ; 00-401178D , Lot Number 19DBE720 ; 00-401178D , Lot Number 22EBH149 ; 00-401178D , Lot Number 22EBM830 ; 00-401178D , Lot Number 22FBC591 ; 00-401178D , Lot Number 19QBB031 ; 00-401178D , Lot Number 19FBO535 ; 00-401178D , Lot Number 19HBD335 ; 00-401178D , Lot Number 19HBL210 ; 00-401178D , Lot Number 19TBA953 ; 00-401178D , Lot Number 19IBT483 ; 00-401178D , Lot Number 19WBA102 ; 00-401178D , Lot Number 20BBV182 ; 00-401178D , Lot Number 23GBA077 ; 00-401178D , Lot Number 23IBD072 ; 00-401178D , Lot Number 20EBL946 ; 00-401178D , Lot Number 20EBQ066 ; 00-401178D , Lot Number 23JBX555 ; 00-401178D , Lot Number 23LBA996 ; 00-401178D , Lot Number 20HBN507 ; 00-401178D , Lot Number 20KBO499 ; 00-401178D , Lot Number 20KBV728 ; 00-401178D , Lot Number 21BBF508 ; 00-401178D , Lot Number 21CBJ453 ; 00-401178D , Lot Number 21DBL052 ; 00-401189I , Lot Number 21HBG663 ; 00-401189I , Lot Number 21JBB680 ; 00-401189I , Lot Number 21KBB008 ; 00-401189I , Lot Number 21LBP957 ; 00-401189I , Lot Number 22ABI341 ; 00-401189I , Lot Number 19ABN868 ; 00-401189I , Lot Number 22NBB684 ; 00-401189I , Lot Number 19CBA463 ; 00-401189I , Lot Number 19DBM041 ; 00-401189I , Lot Number 19DBR193 ; 00-401189I , Lot Number 22EBT294 ; 00-401189I , Lot Number 22FBS446 ; 00-401189I , Lot Number 19FBS077 ; 00-401189I , Lot Number 22IBB089 ; 00-401189I , Lot Number 19SBF248 ; 00-401189I , Lot Number 22IBQ591 ; 00-401189I , Lot Number 22KBJ464 ; 00-401189I , Lot Number 19JBH779 ; 00-401189I , Lot Number 22L...

Label field

Details supplied by the agency

Lot, code or applicability

00-398281J , Lot Number 19FBL693 ; 00-398281J , Lot Number 19HBQ768 ; 00-398281J , Lot Number 19IBJ984 ; 00-398281J , Lot Number 19JBM853 ; 00-398650AG, Lot Number 19ABM946 ; 00-398650AG, Lot Number 19BBS748 ; 00-398650AG, Lot Number 19CBJ825 ; 00-398650AG, Lot Number 19DBR708 ; 00-398650AG, Lot Number 19FBR243 ; 00-398650AG, Lot Number 19IBV635 ; 00-398650AG, Lot Number 19KBL462 ; 00-398650AG, Lot Number 20MBA140 ; 00-398650AG, Lot Number 20EBE408 ; 00-398650AG, Lot Number 20FBJ771 ; 00-398650AG, Lot Number 20HBI575 ; 00-398650AG, Lot Number 20JBJ100 ; 00-398650AG, Lot Number 21ABP363 ; 00-398650AG, Lot Number 21ABQ027 ; 00-398650AI, Lot Number 21FBT441 ; 00-398650AI, Lot Number 21IBH355 ; 00-398650AI, Lot Number 21KBM869 ; 00-398650AI, Lot Number 21LBH937 ; 00-398650AI, Lot Number 22BBA596 ; 00-398650AI, Lot Number 22CBY494 ; 00-398650AI, Lot Number 22DBQ496 ; 00-398650AI, Lot Number 22FBL546 ; 00-398650AI, Lot Number 22GBJ321 ; 00-398650AI, Lot Number 22JBE607 ; 00-398650AI, Lot Number 22JBE609 ; 00-398650AI, Lot Number 21EBB527 ; 00-398712S , Lot Number 19KMA101 ; 00-398712S , Lot Number 19LMB722 ; 00-398712S , Lot Number 20CMA260 ; 00-398712S , Lot Number 20CMC911 ; 00-398712S , Lot Number 20FMA921 ; 00-398712S , Lot Number 20GMB435 ; 00-398712S , Lot Number 20IMA653 ; 00-398712S , Lot Number 20KMA809 ; 00-398712S , Lot Number 20LMD895 ; 00-398712S , Lot Number 21CMD722 ; 00-398712S , Lot Number 21EMF323 ; 00-398712S , Lot Number 21HMB142 ; 00-398712S , Lot Number 21IMB825 ; 00-398712S , Lot Number 21JMH910 ; 00-398712S , Lot Number 21LMG148 ; 00-398712S , Lot Number 22BMH320 ; 00-398712S , Lot Number 22DME594 ; 00-398712S , Lot Number 22HMI166 ; 00-398712S , Lot Number 22JME059 ; 00-398712S , Lot Number 23AME236 ; 00-398712S , Lot Number 23DME416 ; 00-398712S , Lot Number 23FMG905 ; 00-398712S , Lot Number 23IMF984 ; 00-398712S , Lot Number 23KMF990 ; 00-398712S , Lot Number 19BKB212 ; 00-398712S , Lot Number 19CKB198 ; 00-398712S , Lot Number 19EKB257 ; 00-398712S , Lot Number 19GKC485 ; 00-398712S , Lot Number 19IKA568 ; 00-398712S , Lot Number 19IKB991 ; 00-398725AM, Lot Number 21FBJ550 ; 00-398725AM, Lot Number 19IBJ529 ; 00-398725AM, Lot Number 19KBS571 ; 00-398725AM, Lot Number 19KBU397 ; 00-398725AM, Lot Number 20BBE698 ; 00-398725AM, Lot Number 20CBG353 ; 00-398725AM, Lot Number 20DBI198 ; 00-398725AM, Lot Number 20FBB296 ; 00-398725AM, Lot Number 20FBC302 ; 00-398725AM, Lot Number 20GBF723 ; 00-398725AM, Lot Number 20HBM698 ; 00-398725AM, Lot Number 20LBR908 ; 00-398725AM, Lot Number 21BBE202 ; 00-398725AM, Lot Number 21DBD638 ; 00-399360K , Lot Number 21VBC685 ; 00-399360K , Lot Number 23FBU384 ; 00-399360K , Lot Number 23IBA381 ; 00-399360K , Lot Number 23KBE043 ; 00-399360K , Lot Number 23LBR853 ; 00-399734N , Lot Number 23JBU818 ; 00-399734N , Lot Number 23KBI990 ; 00-399734N , Lot Number 23LBV170 ; 00-399734N , Lot Number 19ADB519 ; 00-399734N , Lot Number 19BDB357 ; 00-399734N , Lot Number 19DDA161 ; 00-399734N , Lot Number 19EDA281 ; 00-399734N , Lot Number 19EDC270 ; 00-399734N , Lot Number 19GDA275 ; 00-399734N , Lot Number 19IDA132 ; 00-399734N , Lot Number 19LMA267 ; 00-399734N , Lot Number 20BMA475 ; 00-399734N , Lot Number 20DMA774 ; 00-399734N , Lot Number 20GMB326 ; 00-399734N , Lot Number 20IMD767 ; 00-399734N , Lot Number 20JMC215 ; 00-399734N , Lot Number 21DMA867 ; 00-399734N , Lot Number 21DME739 ; 00-399734N , Lot Number 21FMF556 ; 00-399734N , Lot Number 21IMA047 ; 00-399734N , Lot Number 21JME290 ; 00-399734N , Lot Number 21JMH037 ; 00-399734N , Lot Number 22CMF020 ; 00-399734N , Lot Number 22DMF495 ; 00-399734N , Lot Number 22GMB900 ; 00-399734N , Lot Number 22IMA125 ; 00-399734N , Lot Number 22JME374 ; 00-399734N , Lot Number 22LMB989 ; 00-399734N , Lot Number 23DMA849 ; 00-399734N , Lot Number 23EMC285 ; 00-399734N , Lot Number 23EMJ483 ; 00-399983Q , Lot Number 19BBE921 ; 00-399983Q , Lot Number 19CBY031 ; 00-399983Q , Lot Number 19PBC257 ; 00-399983Q , Lot Number 19FBR534 ; 00-399983Q , Lot Number 19HBF178 ; 00-399983Q , Lot Number 19KBF830 ; 00-399983Q , Lot Number 19LBP680 ; 00-399983Q , Lot Number 20ABX119 ; 00-399983Q , Lot Number 20CBX476 ; 00-399983Q , Lot Number 20EMA308 ; 00-399983Q , Lot Number 20GMA221 ; 00-399983Q , Lot Number 20HMD089 ; 00-399983Q , Lot Number 20JMA848 ; 00-399983Q , Lot Number 20JMC961 ; 00-399983Q , Lot Number 21AMB499 ; 00-399983R , Lot Number 21DMF325 ; 00-399983R , Lot Number 21GMD901 ; 00-399983R , Lot Number 21HMA462 ; 00-399983R , Lot Number 21KMF309 ; 00-399983R , Lot Number 21KMH211 ; 00-399983R , Lot Number 21LMA509 ; 00-399983R , Lot Number 22AME571 ; 00-399983R , Lot Number 22EMC467 ; 00-399983R , Lot Number 22HME724 ; 00-399983R , Lot Number 22KMB997 ; 00-399983R , Lot Number 23AMA130 ; 00-399983R , Lot Number 23CMA230 ; 00-400065K , Lot Number 21FBR263 ; 00-400065K , Lot Number 21HBB836 ; 00-400065K , Lot Number 21JBL879 ; 00-400065K , Lot Number 21KBF878 ; 00-400065K , Lot Number 21LBU544 ; 00-400065K , Lot Number 22BBG118 ; 00-400065K , Lot Number 19ABB720 ; 00-400065K , Lot Number 22CBU488 ; 00-400065K , Lot Number 19BBQ915 ; 00-400065K , Lot Number 19CBM065 ; 00-400065K , Lot Number 22DBP187 ; 00-400065K , Lot Number 19DBM042 ; 00-400065K , Lot Number 22EBP317 ; 00-400065K , Lot Number 19EBX671 ; 00-400065K , Lot Number 22HBF260 ; 00-400065K , Lot Number 19GBN148 ; 00-400065K , Lot Number 22KBG632 ; 00-400065K , Lot Number 19JBB584 ; 00-400065K , Lot Number 19JBI267 ; 00-400065K , Lot Number 22LBO309 ; 00-400065K , Lot Number 23ABG526 ; 00-400065K , Lot Number 23BBQ040 ; 00-400065K , Lot Number 19KBY541 ; 00-400065K , Lot Number 23CBJ011 ; 00-400065K , Lot Number 20MBA423 ; 00-400065K , Lot Number 20CBC516 ; 00-400065K , Lot Number 20DBM271 ; 00-400065K , Lot Number 20FBD765 ; 00-400065K , Lot Number 20GBH479 ; 00-400065K , Lot Number 20HBW054 ; 00-400065K , Lot Number 20JBN060 ; 00-400065K , Lot Number 20KBW249 ; 00-400065K , Lot Number 21BBD722 ; 00-400065K , Lot Number 21CBV490 ; 00-400069F , Lot Number 21GBJ540 ; 00-400069F , Lot Number 21HBN535 ; 00-400069F , Lot Number 21JBV864 ; 00-400069F , Lot Number 19KBY112 ; 00-400069F , Lot Number 19KBZ300 ; 00-400069F , Lot Number 19LBT262 ; 00-400069F , Lot Number 20ABA121 ; 00-400069F , Lot Number 20ABE706 ; 00-400069F , Lot Number 20FBH567 ; 00-400069F , Lot Number 20FBU536 ; 00-400069F , Lot Number 20HBM357 ; 00-400069F , Lot Number 20IBI988 ; 00-400069F , Lot Number 20JBE618 ; 00-400069F , Lot Number 20LBM288 ; 00-400069F , Lot Number 20LBM394 ; 00-400069F , Lot Number 20LBR652 ; 00-400069F , Lot Number 21ABB713 ; 00-400069F , Lot Number 21CBR762 ; 00-400123AC, Lot Number 19ABQ452 ; 00-400123AC, Lot Number 19BBN072 ; 00-400123AC, Lot Number 19BBT797 ; 00-400123AC, Lot Number 19CBR393 ; 00-400123AC, Lot Number 19DBP114 ; 00-400123AC, Lot Number 19EBR874 ; 00-400123AC, Lot Number 19EBZ557 ; 00-400123AC, Lot Number 19GBW344 ; 00-400123AC, Lot Number 19VBA449 ; 00-400123AC, Lot Number 19LBE973 ; 00-400123AC, Lot Number 20BBI940 ; 00-400123AC, Lot Number 20CBU720 ; 00-400123AC, Lot Number 20FBC048 ; 00-400123AD, Lot Number 21GBB662 ; 00-400123AD, Lot Number 21HBE405 ; 00-400123AD, Lot Number 21JBT553 ; 00-400123AD, Lot Number 21JBT555 ; 00-400123AD, Lot Number 21LBM691 ; 00-400123AD, Lot Number 22ABN198 ; 00-400123AD, Lot Number 22EBG139 ; 00-400123AD, Lot Number 22GBB778 ; 00-400123AD, Lot Number 20IBL629 ; 00-400123AD, Lot Number 20JBL358 ; 00-400123AD, Lot Number 21ABG411 ; 00-400123AD, Lot Number 21BBD488 ; 00-400123AD, Lot Number 21CBJ466 ; 00-400290D , Lot Number 21JBL730 ; 00-400290D , Lot Number 21JBL760 ; 00-400290D , Lot Number 22BBL397 ; 00-400290D , Lot Number 22DBD105 ; 00-400290D , Lot Number 22HBX245 ; 00-400290D , Lot Number 22IBJ158 ; 00-400290D , Lot Number 23ABM361 ; 00-400290D , Lot Number 23FBB540 ; 00-400290D , Lot Number 23HBW414 ; 00-400290D , Lot Number 23KBQ874 ; 00-400305Q , Lot Number 21FBH829 ; 00-400305Q , Lot Number 19BBI732 ; 00-400305Q , Lot Number 19CBT638 ; 00-400305Q , Lot Number 19FBK838 ; 00-400305Q , Lot Number 19HBQ608 ; 00-400305Q , Lot Number 19JBF448 ; 00-400305Q , Lot Number 19KBK353 ; 00-400305Q , Lot Number 19LBT845 ; 00-400305Q , Lot Number 20CBX252 ; 00-400305Q , Lot Number 20EBB804 ; 00-400305Q , Lot Number 20EBO003 ; 00-400305Q , Lot Number 20FBD660 ; 00-400305Q , Lot Number 20FBK609 ; 00-400305Q , Lot Number 20GBB363 ; 00-400305Q , Lot Number 20GBT691 ; 00-400305Q , Lot Number 20KBN359 ; 00-400305Q , Lot Number 21ABG937 ; 00-400763F , Lot Number 19ABQ264 ; 00-400763F , Lot Number 19CBJ552 ; 00-400763F , Lot Number 19EBI331 ; 00-400763F , Lot Number 19FBK986 ; 00-400763F , Lot Number 20CBL280 ; 00-400763F , Lot Number 20DBV350 ; 00-400763F , Lot Number 20FBI815 ; 00-400763F , Lot Number 20HBD412 ; 00-400763F , Lot Number 20XBG604 ; 00-400763F , Lot Number 21ABL875 ; 00-400763F , Lot Number 21BBC738 ; 00-400863J , Lot Number 22HBU529 ; 00-400863J , Lot Number 23ABJ577 ; 00-400932O , Lot Number 19BBU120 ; 00-400932O , Lot Number 19CBR446 ; 00-400932O , Lot Number 19EBA051 ; 00-400932O , Lot Number 19FBB043 ; 00-401030S , Lot Number 19ABV014 ; 00-401030S , Lot Number 19CBE728 ; 00-401030S , Lot Number 19DBG910 ; 00-401030S , Lot Number 19QBC207 ; 00-401030S , Lot Number 19FBK697 ; 00-401030S , Lot Number 19JBH635 ; 00-401030S , Lot Number 19KBH432 ; 00-401030S , Lot Number 20BBS390 ; 00-401030S , Lot Number 23HBC817 ; 00-401030S , Lot Number 23IBG655 ; 00-401030S , Lot Number 23JBU657 ; 00-401030S , Lot Number 23LBA284 ; 00-401030S , Lot Number 23LBK479 ; 00-401030S , Lot Number 20FMB629 ; 00-401030S , Lot Number 20HMA737 ; 00-401030S , Lot Number 20IMB800 ; 00-401030S , Lot Number 20JMD194 ; 00-401030S , Lot Number 20LMC207 ; 00-401030S , Lot Number 20LME822 ; 00-401030S , Lot Number 21GMC427 ; 00-401030S , Lot Number 21IMA147 ; 00-401030S , Lot Number 21IME724 ; 00-401030S , Lot Number 22AMB985 ; 00-401030S , Lot Number 22AMG093 ; 00-401030S , Lot Number 22BMF120 ; 00-401030S , Lot Number 22EMC963 ; 00-401030S , Lot Number 22FMF626 ; 00-401030S , Lot Number 22IMB853 ; 00-401030S , Lot Number 22JME308 ; 00-401030S , Lot Number 22KMG715 ; 00-401030S , Lot Number 23BMA914 ; 00-401030S , Lot Number 23BME201 ; 00-401030S , Lot Number 23DMB789 ; 00-401030S , Lot Number 23EMC356 ; 00-401030S , Lot Number 23FMB166 ; 00-401178D , Lot Number 21GBC991 ; 00-401178D , Lot Number 21KBI883 ; 00-401178D , Lot Number 21LBM169 ; 00-401178D , Lot Number 22ABX434 ; 00-401178D , Lot Number 19ABG094 ; 00-401178D , Lot Number 22BBW843 ; 00-401178D , Lot Number 19DBE720 ; 00-401178D , Lot Number 22EBH149 ; 00-401178D , Lot Number 22EBM830 ; 00-401178D , Lot Number 22FBC591 ; 00-401178D , Lot Number 19QBB031 ; 00-401178D , Lot Number 19FBO535 ; 00-401178D , Lot Number 19HBD335 ; 00-401178D , Lot Number 19HBL210 ; 00-401178D , Lot Number 19TBA953 ; 00-401178D , Lot Number 19IBT483 ; 00-401178D , Lot Number 19WBA102 ; 00-401178D , Lot Number 20BBV182 ; 00-401178D , Lot Number 23GBA077 ; 00-401178D , Lot Number 23IBD072 ; 00-401178D , Lot Number 20EBL946 ; 00-401178D , Lot Number 20EBQ066 ; 00-401178D , Lot Number 23JBX555 ; 00-401178D , Lot Number 23LBA996 ; 00-401178D , Lot Number 20HBN507 ; 00-401178D , Lot Number 20KBO499 ; 00-401178D , Lot Number 20KBV728 ; 00-401178D , Lot Number 21BBF508 ; 00-401178D , Lot Number 21CBJ453 ; 00-401178D , Lot Number 21DBL052 ; 00-401189I , Lot Number 21HBG663 ; 00-401189I , Lot Number 21JBB680 ; 00-401189I , Lot Number 21KBB008 ; 00-401189I , Lot Number 21LBP957 ; 00-401189I , Lot Number 22ABI341 ; 00-401189I , Lot Number 19ABN868 ; 00-401189I , Lot Number 22NBB684 ; 00-401189I , Lot Number 19CBA463 ; 00-401189I , Lot Number 19DBM041 ; 00-401189I , Lot Number 19DBR193 ; 00-401189I , Lot Number 22EBT294 ; 00-401189I , Lot Number 22FBS446 ; 00-401189I , Lot Number 19FBS077 ; 00-401189I , Lot Number 22IBB089 ; 00-401189I , Lot Number 19SBF248 ; 00-401189I , Lot Number 22IBQ591 ; 00-401189I , Lot Number 22KBJ464 ; 00-401189I , Lot Number 19JBH779 ; 00-401189I , Lot Number 22L...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Sep 18, 2024
Recall initiation date: Apr 8, 2024
Center classification date: Sep 6, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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