Recall archive / FDA device enforcement
Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS78... — FDA record Z-3002-2024
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) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ; 6) CAROTID CDS-LF, Pack Number CDS840056N ; 7) CAROTID-LF, Pack Number CDS860039J ; 8) T & A PROCEDURE-LF, Pack Number CDS860047X ; 9) THORACOTOMY CDS , Pack Number CDS920065R ; 10) EAR CDS , Pack Number CDS980089L ; 11) EAR CDS , Pack Number CDS980089M ; 12) EAR CDS , Pack Number CDS980089N ; 13) EAR CDS , Pack Number CDS980089O ; 14) ENDOSCOPY , Pack Number CDS980201R ; 15) TYMPANOPLASTY , Pack Number CDS980203R ; 16) TYMPANOPLASTY , Pack Number CDS980203S ; 17) TYMPANO CDS , Pack Number CDS980374M ; 18) TYMPANO CDS , Pack Number CDS980374O ; 19) TYMPANO CDS , Pack Number CDS980374P ; 20) THORACOTOMY CDS , Pack Number CDS980446T ; 21) SINUS CDS , Pack Number CDS980579D ; 22) EENT-HEAD AND NECK, Pack Number CDS980809K ; 23) EENT-HEAD AND NECK, Pack Number CDS980809L ; 24) EENT-HEAD AND NECK, Pack Number CDS980809M ; 25) FESS PROCEDURE, Pack Number CDS981185B ; 26) CDS981571P, Pack Number CDS981571P ; 27) SINUS CDS-LF, Pack Number CDS981692J ; 28) EAR CDS , Pack Number CDS981985F ; 29) MAJOR EAR , Pack Number CDS982016Q ; 30) MAJOR EAR , Pack Number CDS982016R ; 31) MAJOR EAR , Pack Number CDS982016S ; 32) MAJOR EAR , Pack Number CDS982016T ; 33) SINUS , Pack Number CDS982020O ; 34) SINUS , Pack Number CDS982020P ; 35) SINUS , Pack Number CDS982020R ; 36) NASAL/SEPTAL, Pack Number CDS982049M; 37) NASAL/SEPTAL, Pack Number CDS982049O; 38) T&A CDS-LF, Pack Number CDS982091I ; 39) EAR-EENT CDS, Pack Number CDS982307F ; 40) EAR-EENT CDS, Pack Number CDS982307G ; 41) EAR-EENT CDS, Pack Number CDS982307J ; 42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ; 43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ; 44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ; 45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ; 46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ; 47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ; 48) EAR CDS-LF, Pack Number CDS982612B ; 49) T AND A CDS MRH , Pack Number CDS982622L ; 50) CAROTID , Pack Number CDS982638J ; 51) NASAL CDS , Pack Number CDS982655C ; 52) NASAL CDS , Pack Number CDS982655D ; 53) NASAL CDS , Pack Number CDS982655F ; 54) NECK THYROID, Pack Number CDS982692M ; 55) NECK THYROID, Pack Number CDS982692N ; 56) NECK THYROID, Pack Number CDS982692O ; 57) TYMPANOPLASTY , Pack Number CDS982720N ; 58) TYMPANOPLASTY , Pack Number CDS982720P ; 59) TYMPANOPLASTY , Pack Number CDS982720Q ; 60) TYMPANOPLASTY , Pack Number CDS982720R ; 61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ; 62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ; 63) SINUS CDS-1 , Pack Number CDS982901F ; 64) MIDDLE EAR CDS, Pack Number CDS982938J ; 65) MIDDLE EAR CDS, Pack Number CDS982938K ; 66) MIDDLE EAR CDS, Pack Number CDS982938L ; 67) MIDDLE EAR CDS, Pack Numb...
- 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-3002-2024
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 | AM310B , Lot Number 20BBX607 ; AM310B , Lot Number 20FBO876 ; AM310B , Lot Number 20HBG464 ; AM310B , Lot Number 20HBT869 ; AM310B , Lot Number 20JBW307 ; AM310B , Lot Number 20XBG776 ; CDS780161K , Lot Number 19ABJ175 ; CDS780161K , Lot Number 19CBC247 ; CDS780161K , Lot Number 19DBJ688 ; CDS780161L , Lot Number 21FBM662 ; CDS780161L , Lot Number 21JBO079 ; CDS780161L , Lot Number 21KBU620 ; CDS780161L , Lot Number 22DBN197 ; CDS780161L , Lot Number 22EBE676 ; CDS780161L , Lot Number 22GBA238 ; CDS780161L , Lot Number 19FBZ495 ; CDS780161L , Lot Number 22HBH827 ; CDS780161L , Lot Number 22JBA466 ; CDS780161L , Lot Number 22JBR842 ; CDS780161L , Lot Number 19IBA021 ; CDS780161L , Lot Number 22LBG736 ; CDS780161L , Lot Number 23ABC482 ; CDS780161L , Lot Number 19KBD885 ; CDS780161L , Lot Number 23BBK773 ; CDS780161L , Lot Number 23DBH567 ; CDS780161L , Lot Number 20BBA048 ; CDS780161L , Lot Number 23EBW865 ; CDS780161L , Lot Number 23FBR465 ; CDS780161L , Lot Number 20CBF643 ; CDS780161L , Lot Number 23HBF094 ; CDS780161L , Lot Number 20DBQ527 ; CDS780161L , Lot Number 20EBT660 ; CDS780161L , Lot Number 23JBG854 ; CDS780161L , Lot Number 23KBG199 ; CDS780161L , Lot Number 20GBQ310 ; CDS780161L , Lot Number 20HBW040 ; CDS780161L , Lot Number 20KBQ319 ; CDS780161L , Lot Number 20LBP102 ; CDS780161L , Lot Number 20LBQ550 ; CDS780161L , Lot Number 21CBI795 ; CDS780161L , Lot Number 21DBA543 ; CDS780161L , Lot Number 21EBA173 ; CDS780170R , Lot Number 21HBH210 ; CDS780170R , Lot Number 19ABX183 ; CDS780170R , Lot Number 19CBG446 ; CDS780170R , Lot Number 19DBV563 ; CDS780170R , Lot Number 19GBW741 ; CDS780170R , Lot Number 19IBQ678 ; CDS780170R , Lot Number 20BBE129 ; CDS780170R , Lot Number 20HBH841 ; CDS780170R , Lot Number 20JBY348 ; CDS780170R , Lot Number 20KBE437 ; CDS780170R , Lot Number 21BBN563 ; CDS780170R , Lot Number 21EBO719 ; CDS780170S , Lot Number 21LBU027 ; CDS780170S , Lot Number 22ABC196 ; CDS780170S , Lot Number 22CBT534 ; CDS780170S , Lot Number 22DBB138 ; CDS780170S , Lot Number 22FBY456 ; CDS780170S , Lot Number 22LMJ227 ; CDS780170S , Lot Number 23AMB457 ; CDS780170S , Lot Number 23AMG031 ; CDS780170S , Lot Number 23BMG081 ; CDS840056N , Lot Number 19ABS578 ; CDS840056N , Lot Number 19CBF638 ; CDS840056N , Lot Number 19DBQ238 ; CDS840056N , Lot Number 19FBT067 ; CDS840056N , Lot Number 19JBJ675 ; CDS860039J , Lot Number 21GBL272 ; CDS860039J , Lot Number 20FBR859 ; CDS860039J , Lot Number 20HBH825 ; CDS860039J , Lot Number 20JBI204 ; CDS860039J , Lot Number 20KBJ538 ; CDS860039J , Lot Number 20LBV021 ; CDS860039J , Lot Number 21CBO329 ; CDS860039J , Lot Number 21EBA033 ; CDS860039J , Lot Number 21EBO476 ; CDS860047X , Lot Number 22KBF748 ; CDS860047X , Lot Number 23ABC310 ; CDS860047X , Lot Number 23BBN857 ; CDS860047X , Lot Number 23CBM719 ; CDS860047X , Lot Number 23CBR360 ; CDS860047X , Lot Number 23DBP426 ; CDS860047X , Lot Number 23EBK702 ; CDS860047X , Lot Number 23FBE714 ; CDS860047X , Lot Number 23GBU901 ; CDS860047X , Lot Number 23HBU599 ; CDS860047X , Lot Number 23IBO885 ; CDS920065R , Lot Number 22JLB054 ; CDS980089L , Lot Number 19BBE268 ; CDS980089L , Lot Number 19CBL613 ; CDS980089L , Lot Number 19FBL680 ; CDS980089L , Lot Number 19TBC919 ; CDS980089L , Lot Number 19JBK959 ; CDS980089M , Lot Number 21FBJ093 ; CDS980089M , Lot Number 21FBJ094 ; CDS980089M , Lot Number 21FBJ095 ; CDS980089M , Lot Number 21FBJ096 ; CDS980089M , Lot Number 21FBJ097 ; CDS980089M , Lot Number 21FBR314 ; CDS980089M , Lot Number 21HBG999 ; CDS980089M , Lot Number 21JBM584 ; CDS980089M , Lot Number 19KBH835 ; CDS980089M , Lot Number 20HBU008 ; CDS980089M , Lot Number 20LBI140 ; CDS980089M , Lot Number 21BBJ367 ; CDS980089N , Lot Number 22ABD323 ; CDS980089N , Lot Number 22ABD324 ; CDS980089N , Lot Number 22KBM192 ; CDS980089O , Lot Number 23CBW365 ; CDS980089O , Lot Number 23EBE453 ; CDS980089O , Lot Number 23GBB537 ; CDS980089O , Lot Number 23JBN802 ; CDS980089O , Lot Number 23LBJ396 ; CDS980201R , Lot Number 22CBB940 ; CDS980201R , Lot Number 22OBA201 ; CDS980203R , Lot Number 19ABW857 ; CDS980203R , Lot Number 19BBU024 ; CDS980203R , Lot Number 19DBY788 ; CDS980203R , Lot Number 19QBA275 ; CDS980203R , Lot Number 19SBB846 ; CDS980203R , Lot Number 19LBJ447 ; CDS980203R , Lot Number 20BBE176 ; CDS980203R , Lot Number 20DBT319 ; CDS980203R , Lot Number 20EBA269 ; CDS980203R , Lot Number 20HBI823 ; CDS980203R , Lot Number 20IBQ932 ; CDS980203R , Lot Number 20KBF449 ; CDS980203R , Lot Number 21ABI747 ; CDS980203S , Lot Number 21GBS679 ; CDS980203S , Lot Number 21IBV658 ; CDS980203S , Lot Number 21KBI373 ; CDS980203S , Lot Number 21KBK367 ; CDS980203S , Lot Number 21LBJ704 ; CDS980203S , Lot Number 22ABF195 ; CDS980203S , Lot Number 22FBG171 ; CDS980203S , Lot Number 22HBO399 ; CDS980203S , Lot Number 22HBS783 ; CDS980203S , Lot Number 22KBS200 ; CDS980203S , Lot Number 22LBH807 ; CDS980203S , Lot Number 22LBH959 ; CDS980203S , Lot Number 23ABR111 ; CDS980203S , Lot Number 23DBT154 ; CDS980203S , Lot Number 23HBT797 ; CDS980203S , Lot Number 23JBM122 ; CDS980203S , Lot Number 23LBC884 ; CDS980203S , Lot Number 21CBW683 ; CDS980374M , Lot Number 19DBV282 ; CDS980374M , Lot Number 19EBW414 ; CDS980374M , Lot Number 19GBF774 ; CDS980374M , Lot Number 19IBB514 ; CDS980374M , Lot Number 19LBE165 ; CDS980374M , Lot Number 20DBH025 ; CDS980374M , Lot Number 20FBJ581 ; CDS980374M , Lot Number 20IBD364 ; CDS980374M , Lot Number 20JBM273 ; CDS980374M , Lot Number 20KBL921 ; CDS980374M , Lot Number 21ABG498 ; CDS980374M , Lot Number 21CBF887 ; CDS980374O , Lot Number 21IBA010 ; CDS980374O , Lot Number 21IBT673 ; CDS980374O , Lot Number 22ABB423 ; CDS980374O , Lot Number 22OBM366 ; CDS980374O , Lot Number 22EBU213 ; CDS980374O , Lot Number 22GBE098 ; CDS980374O , Lot Number 22GBX430 ; CDS980374O , Lot Number 22JBN229 ; CDS980374O , Lot Number 22KBT771 ; CDS980374O , Lot Number 22LBM391 ; CDS980374O , Lot Number 23BBG819 ; CDS980374O , Lot Number 23CBT151 ; CDS980374P , Lot Number 23FBG020 ; CDS980374P , Lot Number 23FBV450 ; CDS980374P , Lot Number 23HBI049 ; CDS980374P , Lot Number 23IBQ190 ; CDS980374P , Lot Number 23KBB054 ; CDS980374P , Lot Number 23KBB055 ; CDS980374P , Lot Number 23KBB070 ; CDS980446T , Lot Number 21FBP535 ; CDS980446T , Lot Number 21FBT733 ; CDS980446T , Lot Number 21IBR112 ; CDS980446T , Lot Number 20GBJ881 ; CDS980446T , Lot Number 20GBW080 ; CDS980446T , Lot Number 20IBG082 ; CDS980446T , Lot Number 20LBS189 ; CDS980446T , Lot Number 21EBE589 ; CDS980579D , Lot Number 21FBN768 ; CDS980579D , Lot Number 21IBA072 ; CDS980579D , Lot Number 21JBC146 ; CDS980579D , Lot Number 22ABD373 ; CDS980579D , Lot Number 22BBU367 ; CDS980579D , Lot Number 19BBJ400 ; CDS980579D , Lot Number 22DBK641 ; CDS980579D , Lot Number 19DBE477 ; CDS980579D , Lot Number 19EBC589 ; CDS980579D , Lot Number 22FBN678 ; CDS980579D , Lot Number 19FBO184 ; CDS980579D , Lot Number 22HBF976 ; CDS980579D , Lot Number 22HBL188 ; CDS980579D , Lot Number 19HBY828 ; CDS980579D , Lot Number 19IBW711 ; CDS980579D , Lot Number 22LBE888 ; CDS980579D , Lot Number 23ABD648 ; CDS980579D , Lot Number 23ABP476 ; CDS980579D , Lot Number 19LBK646 ; CDS980579D , Lot Number 23DBD581 ; CDS980579D , Lot Number 23DBO915 ; CDS980579D , Lot Number 20BBA370 ; CDS980579D , Lot Number 23GBK604 ; CDS980579D , Lot Number 20DBB743 ; CDS980579D , Lot Number 23JBF547 ; CDS980579D , Lot Number 20FBR891 ; CDS980579D , Lot Number 20HBU165 ; CDS980579D , Lot Number 23LBM852 ; CDS980579D , Lot Number 24ABJ712 ; CDS980579D , Lot Number 20JBG228 ; CDS980579D , Lot Number 20LBG157 ; CDS980579D , Lot Number 21ABL742 ; CDS980579D , Lot Number 21EBI490 ; CDS980579D , Lot Number 21FBB075 ; CDS980809K , Lot Number 19BBK881 ; CDS980809K , Lot Number 19CBA199 ; CDS980809K , Lot Number 19CBV529 ; CDS980809K , Lot Number 19HBD987 ; CDS980809L , Lot Number 20CBP755 ; CDS980809L , Lot Number 20DBT299 ; CDS980809L , Lot Number 20EBF598 ; CDS980809L , Lot Number 20FBU281 ; CDS980809L , Lot Number 21CBQ757 ; CDS980809M , Lot Number 22CBK304 ; CDS980809M , Lot Number 22OBE744 ; CDS980809M , Lot Number 22EBG583 ; CDS980809M , Lot Number 22EBI113 ; CDS980809M , Lot Number 22JBP033 ; CDS980809M , Lot Number 23BBK767 ; CDS980809M , Lot Number 23DBI050 ; CDS980809M , Lot Number 23FBP394 ; CDS981185B , Lot Number 19CDB151 ; CDS981185B , Lot Number 19DDD096 ; CDS981185B , Lot Number 19FDA612 ; CDS981185B , Lot Number 19IDA540 ; CDS981185B , Lot Number 19LDB150 ; CDS981185B , Lot Number 20BDA647 ; CDS981185B , Lot Number 20DDB481 ; CDS981185B , Lot Number 20IDA733 ; CDS981185B , Lot Number 20LDA459 ; CDS981185B , Lot Number 21HDB855 ; CDS981185B , Lot Number 21IDA882 ; CDS981185B , Lot Number 21JDB377 ; CDS981185B , Lot Number 22CDC141 ; CDS981185B , Lot Number 22EDB625 ; CDS981185B , Lot Number 23ADB195 ; CDS981185B , Lot Number 23FDA168 ; CDS981185B , Lot Number 23GDA870 ; CDS981185B , Lot Number 23LDB380 ; CDS981185B , Lot Number 24BDB518 ; CDS981571P , Lot Number 20IBF435 ; CDS981571P , Lot Number 20JBD456 ; CDS981571P , Lot Number 20KBY135 ; CDS981571P , Lot Number 21ABG837 ; CDS981692J , Lot Number 21EME021 ; CDS981692J , Lot Number 21FMB792 ; CDS981692J , Lot Number 21FMD781 ; CDS981692J , Lot Number 21GMC528 ; CDS981692J , Lot Number 21HMF136 ; CDS981692J , Lot Number 21KMA503 ; CDS981692J , Lot Number 22AMA586 ; CDS981692J , Lot Number 22EMB645 ; CDS981692J , Lot Number 22GMB473 ; CDS981692J , Lot Number 22GMH942 ; CDS981692J , Lot Number 22IMD591 ; CDS981692J , Lot Number 22KMG745 ; CDS981692J , Lot Number 22LME628 ; CDS981692J , Lot Number 23CME129 ; CDS981692J , Lot Number 19CKB351 ; CDS981692J , Lot Number 19EKA839 ; CDS981692J , Lot Number 19IKA266 ; CDS981692J , Lot Number 19JKC199 ; CDS981692J , Lot Number 19LKB014 ; CDS981692J , Lot Number 20BKA891 ; CDS981692J , Lot Number 20GKB237 ; CDS981692J , Lot Number 20HKB816 ; CDS981692J , Lot Number 20KKA424 ; CDS981692J , Lot Number 20LKA784 ; CDS981985F , Lot Number 21FBL045 ; CDS981985F , Lot Number 21GBN303 ; CDS981985F , Lot Number 22EBF907 ; CDS981985F , Lot Number 22GBG130 ; CDS981985F , Lot Number 22GBV850 ; CDS981985F , Lot Number 19GBX996 ; CDS981985F , Lot Number 22IBS673 ; CDS981985F , Lot Number 22JBB341 ; CDS981985F , Lot Number 22LBJ141 ; CDS981985F , Lot Number 22LBJ307 ; CDS981985F , Lot Number 19JBX763 ; CDS981985F , Lot Number 20DBG940 ; CDS981985F , Lot Number 20EBI924 ; CDS981985F , Lot Number 23LBE996 ; CDS981985F , Lot Number 20KBY217 ; CDS981985F , Lot Number 20XBC512 ; CDS981985F , Lot Number 21DBG165 ; CDS981985F , Lot Number 21DBH201 ; CDS982016Q , Lot Number 19BBF890 ; CDS982016Q , Lot Number 19CBF185 ; CDS982016Q , Lot Number 19DBA660 ; CDS982016Q , Lot Number 19PBB975 ; CDS982016R , Lot Number 19GBI419 ; CDS982016R , Lot Number 19HBN034 ; CDS982016R , Lot Number 19IBZ477 ; CDS982016R , Lot Number 19LBP464 ; CDS982016R , Lot Number 20CBA306 ; CDS982016R , Lot Number 20EBC136 ; CDS982016R , Lot Number 20GBH774 ; CDS982016R , Lot Number 20HBG780 ; CDS982016R , Lot Number 20WBA492 ; CDS982016R , Lot Number 21BBQ621 ; CDS982016R , Lot Number 21CBK113 ; CDS982016R , Lot Number 21DBI890 ; CDS982016R , Lot Number 21DBI891 ; CDS982016S , Lot Number 21FBT757 ; CDS982016S , Lot Number 21HBE591 ; CDS982016S , Lot Number 21IBU098 ; CDS982016T , Lot Number 22BBV007 ; CDS982016T , Lot Number 22CBP238 ; CDS982016T , Lot Number 22OBL829 ; CDS982016T , Lot Number 22GBM951 ; CDS982016T , Lot Number 22GBO165 ; CDS982016T , Lot Number 22HBS644 ; CDS982020O , Lot Number 19BBC336 ; CDS982020O , Lot Number 19DBA628 ; CDS982020O , Lot Number 19EBW738 ; CDS982020P , Lot Number 19SBB547 ; CDS982020P , Lot Number 19JBM880 ; CDS982020P , Lot Number 19LBO283 ; CDS982020P , Lot Number 20BBW773 ; CDS982020P , Lot Number 20EBD313 ; CDS982020P , Lot Number 20EBO346 ; CDS982020R , Lot Number 22JBW425 ; CDS982020R , Lot Number 23ABM479 ; CDS982020R , Lot Number 23CBX462 ; CDS982020R , Lot Number 23EBP721 ; CDS982020R , Lot Number 23FBN485 ; CDS982020R , Lot Number 23GBM193 ; CDS982049M, Lot ... |
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.