Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, P... — FDA record Z-3042-2024

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 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS780056L ; 6) SHUNT CDS-LF, Pack Number CDS780103K ; 7) NEURO CDS , Pack Number CDS780108T ; 8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ; 9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ; 10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ; 11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ; 12) NEURO CDS , Pack Number CDS780162AA; 13) NEURO CDS , Pack Number CDS780162AB; 14) NEURO CDS , Pack Number CDS780162AC; 15) NEURO CDS , Pack Number CDS780162AD; 16) NEURO CDS , Pack Number CDS780162X ; 17) NEURO CDS , Pack Number CDS780162Y ; 18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ; 19) BASIC NEURO PACK, Pack Number CDS780202L ; 20) BASIC NEURO PACK, Pack Number CDS780202O ; 21) BASIC NEURO PACK, Pack Number CDS780202P ; 22) BASIC NEURO PACK, Pack Number CDS780202Q ; 23) BASIC NEURO PACK, Pack Number CDS780202R ; 24) NEURO-LAMI CDS, Pack Number CDS780208D ; 25) NEURO-LAMI CDS, Pack Number CDS780208F ; 26) NEURO CDS, Pack Number CDS780230K; 27) NEURO CDS , Pack Number CDS780230K ; 28) VP SHUNT, Pack Number CDS840193U ; 29) NEURO CDS-LF, Pack Number CDS980853N ; 30) VP SHUNT CDS-LF , Pack Number CDS981084K ; 31) VP SHUNT CDS-LF , Pack Number CDS981084L ; 32) VP SHUNT CDS-LF , Pack Number CDS981084M ; 33) NEURO KIT , Pack Number CDS981327N ; 34) NEURO KIT , Pack Number CDS981327O ; 35) NEURO KIT , Pack Number CDS981327P ; 36) NERVE STIMULATOR, Pack Number CDS981579N ; 37) NEURO MINOR CDS , Pack Number CDS981708K ; 38) VP SHUNT CDS, Pack Number CDS981740F ; 39) VP SHUNT CDS, Pack Number CDS981740J ; 40) VP SHUNT CDS, Pack Number CDS981740K ; 41) VP SHUNT CDS, Pack Number CDS981740KH; 42) MICRO DISC CDS, Pack Number CDS981886P ; 43) MICRO DISC CDS, Pack Number CDS981886R ; 44) MICRO DISC CDS, Pack Number CDS981886S ; 45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ; 46) NEURO CDS , Pack Number CDS982603L ; 47) NEURO CDS , Pack Number CDS982603M ; 48) NEURO CDS , Pack Number CDS982603N ; 49) NEURO SPINE CDS , Pack Number CDS982683Q ; 50) MAJOR NEURO , Pack Number CDS982704K ; 51) MAJOR NEURO , Pack Number CDS982704M ; 52) MAJOR NEURO , Pack Number CDS982704N ; 53) NEURO CDS CHS-LF, Pack Number CDS982745D ; 54) NEURO CDS CHS-LF, Pack Number CDS982745F ; 55) NEURO CDS CHS-LF, Pack Number CDS982745G ; 56) AV SHUNT CDS, Pack Number CDS983098D ; 57) AV SHUNT CDS, Pack Number CDS983098F ; 58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ; 59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ; 60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ; 61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ; 62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ; 63) VP SHUNT, Pack Number CDS983366J ; 64) VP SHUNT, Pack Number CDS983366M ; 65) VP SHUNT, Pack Number CDS983366N ; 66) VP SHUNT, Pack Number CDS98336...
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-3042-2024

Open the official record

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

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability00-401327AA, Lot Number 20AMA256 ; 00-401327AA, Lot Number 20AMC142 ; 00-401327AA, Lot Number 20BMB258 ; 00-401327AA, Lot Number 20DMB109 ; 00-401327AA, Lot Number 20GMB772 ; 00-401327AA, Lot Number 20HMC035 ; 00-401327AA, Lot Number 20JMA910 ; 00-401327AA, Lot Number 20JMB656 ; 00-401327AA, Lot Number 21CMA167 ; 00-401327AA, Lot Number 21EMB860 ; 00-401327AA, Lot Number 21FMC472 ; 00-401327AA, Lot Number 21GMF286 ; 00-401327AA, Lot Number 21HME693 ; 00-401327AA, Lot Number 21IMC842 ; 00-401327AA, Lot Number 21KMB315 ; 00-401594R , Lot Number 19LDA473 ; 00-401594R , Lot Number 20ADB972 ; 00-401594R , Lot Number 20CDC521 ; 00-401594R , Lot Number 20EDB836 ; 00-401594R , Lot Number 20HDA321 ; 00-401594R , Lot Number 21CDB556 ; 00-401594R , Lot Number 21EDA344 ; 00-401808S , Lot Number 21GBR684 ; 00-401808S , Lot Number 21IBB505 ; 00-401808S , Lot Number 21JBD593 ; 00-401808S , Lot Number 21JBD594 ; 00-401808S , Lot Number 21JBD596 ; 00-401808S , Lot Number 22ABS576 ; 00-401808S , Lot Number 19ABL630 ; 00-401808S , Lot Number 22NBA002 ; 00-401808S , Lot Number 19BBJ217 ; 00-401808S , Lot Number 22OBB643 ; 00-401808S , Lot Number 19DBK655 ; 00-401808S , Lot Number 22FBO951 ; 00-401808S , Lot Number 19FBI621 ; 00-401808S , Lot Number 19FBV633 ; 00-401808S , Lot Number 22HBR194 ; 00-401808S , Lot Number 22IBG899 ; 00-401808S , Lot Number 19HBL271 ; 00-401808S , Lot Number 22JBH625 ; 00-401808S , Lot Number 19IBG849 ; 00-401808S , Lot Number 22KBP137 ; 00-401808S , Lot Number 19IBZ700 ; 00-401808S , Lot Number 22LBN374 ; 00-401808S , Lot Number 19VBC278 ; 00-401808S , Lot Number 19KBQ992 ; 00-401808S , Lot Number 23CBC166 ; 00-401808S , Lot Number 19LBK455 ; 00-401808S , Lot Number 23CBW993 ; 00-401808S , Lot Number 23EBE204 ; 00-401808S , Lot Number 23EBF240 ; 00-401808S , Lot Number 20CBH056 ; 00-401808S , Lot Number 23GBN716 ; 00-401808S , Lot Number 20CBY951 ; 00-401808S , Lot Number 23HBG573 ; 00-401808S , Lot Number 20FBB585 ; 00-401808S , Lot Number 20FBE238 ; 00-401808S , Lot Number 20FBF231 ; 00-401808S , Lot Number 23JBC088 ; 00-401808S , Lot Number 20GBJ388 ; 00-401808S , Lot Number 23KBM084 ; 00-401808S , Lot Number 20JBC354 ; 00-401808S , Lot Number 20LBD734 ; 00-401808S , Lot Number 21CBX182 ; CDS780056K , Lot Number 19BBQ112 ; CDS780056K , Lot Number 19FBQ838 ; CDS780056K , Lot Number 19HBN954 ; CDS780056K , Lot Number 19JBJ354 ; CDS780056K , Lot Number 19KBF418 ; CDS780056K , Lot Number 20BBF089 ; CDS780056K , Lot Number 20OBA309 ; CDS780056K , Lot Number 20DBL328 ; CDS780056K , Lot Number 20GBL494 ; CDS780056K , Lot Number 20GBV115 ; CDS780056K , Lot Number 20KBS804 ; CDS780056K , Lot Number 20WBI356 ; CDS780056K , Lot Number 21DBU610 ; CDS780056L , Lot Number 21IBV394 ; CDS780056L , Lot Number 21KBG946 ; CDS780103K , Lot Number 22OBI238 ; CDS780103K , Lot Number 22FBF458 ; CDS780103K , Lot Number 22HBF971 ; CDS780103K , Lot Number 22HBF972 ; CDS780103K , Lot Number 22IBQ334 ; CDS780103K , Lot Number 22JBR855 ; CDS780103K , Lot Number 22LBB223 ; CDS780103K , Lot Number 23BBD147 ; CDS780103K , Lot Number 23FBQ301 ; CDS780103K , Lot Number 23GBE098 ; CDS780103K , Lot Number 23GBT769 ; CDS780103K , Lot Number 23IBB510 ; CDS780103K , Lot Number 23JBG685 ; CDS780103K , Lot Number 23LBR311 ; CDS780103K , Lot Number 23LBV808 ; CDS780103K , Lot Number 24CBE995 ; CDS780108T , Lot Number 19DLA065 ; CDS780108T , Lot Number 19DLA501 ; CDS780108T , Lot Number 19DLA665 ; CDS780108T , Lot Number 19FLA394 ; CDS780108T , Lot Number 19GLA142 ; CDS780108T , Lot Number 19GLA202 ; CDS780108T , Lot Number 19GLA261 ; CDS780108T , Lot Number 19HLA111 ; CDS780108T , Lot Number 19HLA402 ; CDS780108T , Lot Number 19ILA293 ; CDS780108T , Lot Number 19JLA050 ; CDS780108T , Lot Number 19JLA667 ; CDS780108T , Lot Number 19KLA463 ; CDS780108T , Lot Number 20ALA303 ; CDS780108T , Lot Number 20BLA407 ; CDS780109M , Lot Number 19CBI751 ; CDS780109M , Lot Number 19CBR419 ; CDS780109N , Lot Number 19EBU235 ; CDS780109N , Lot Number 19FBO209 ; CDS780109N , Lot Number 19HBD224 ; CDS780109N , Lot Number 19JBT649 ; CDS780109N , Lot Number 19KBY989 ; CDS780109N , Lot Number 20ABT942 ; CDS780109N , Lot Number 20CBY395 ; CDS780109O , Lot Number 21HBM967 ; CDS780109O , Lot Number 21KBC808 ; CDS780109O , Lot Number 22BBC815 ; CDS780109O , Lot Number 22OBA987 ; CDS780109O , Lot Number 22EBE862 ; CDS780109O , Lot Number 22FBI951 ; CDS780109O , Lot Number 22GBK671 ; CDS780109O , Lot Number 22HBZ276 ; CDS780109O , Lot Number 22IBK666 ; CDS780109O , Lot Number 22KBD840 ; CDS780109O , Lot Number 23ABG956 ; CDS780109O , Lot Number 23CBO553 ; CDS780109O , Lot Number 23DBB223 ; CDS780109O , Lot Number 23EBP966 ; CDS780109O , Lot Number 23FBL915 ; CDS780109O , Lot Number 23HBL622 ; CDS780109O , Lot Number 23HBO324 ; CDS780109O , Lot Number 23IBO480 ; CDS780109O , Lot Number 20HBG092 ; CDS780109O , Lot Number 20HBT149 ; CDS780109O , Lot Number 20WBE680 ; CDS780109O , Lot Number 20LBP961 ; CDS780109O , Lot Number 21DBB965 ; CDS780109O , Lot Number 21DBN004 ; CDS780109O , Lot Number 21FBD640 ; CDS780119T , Lot Number 19DBE959 ; CDS780119T , Lot Number 19DBT828 ; CDS780119T , Lot Number 19EBV096 ; CDS780119T , Lot Number 19GBI935 ; CDS780119T , Lot Number 19HBH508 ; CDS780119T , Lot Number 19JBJ656 ; CDS780119T , Lot Number 20BBD324 ; CDS780119T , Lot Number 20CBP243 ; CDS780119T , Lot Number 20DBK808 ; CDS780119T , Lot Number 20DBQ069 ; CDS780119T , Lot Number 20EBU829 ; CDS780162AA, Lot Number 20BBO888 ; CDS780162AA, Lot Number 20BBQ352 ; CDS780162AA, Lot Number 20FBR735 ; CDS780162AB, Lot Number 20GBF853 ; CDS780162AC, Lot Number 20HBE537 ; CDS780162AC, Lot Number 20IBB263 ; CDS780162AC, Lot Number 20JBB811 ; CDS780162AC, Lot Number 20KBA268 ; CDS780162AC, Lot Number 20LBM232 ; CDS780162AC, Lot Number 21ABA833 ; CDS780162AD, Lot Number 21GBS609 ; CDS780162AD, Lot Number 21HBB525 ; CDS780162AD, Lot Number 21ABU170 ; CDS780162AD, Lot Number 21BBQ045 ; CDS780162AD, Lot Number 21DBD059 ; CDS780162AD, Lot Number 21DBS617 ; CDS780162X , Lot Number 19ABX591 ; CDS780162X , Lot Number 19BBM085 ; CDS780162X , Lot Number 19CBM932 ; CDS780162X , Lot Number 19EBF768 ; CDS780162X , Lot Number 19EBU016 ; CDS780162X , Lot Number 19EBY613 ; CDS780162X , Lot Number 19FBI652 ; CDS780162X , Lot Number 19GBV765 ; CDS780162Y , Lot Number 19RBB546 ; CDS780162Y , Lot Number 19HBC545 ; CDS780162Y , Lot Number 19HBD425 ; CDS780162Y , Lot Number 19JBG849 ; CDS780162Y , Lot Number 19VBH579 ; CDS780162Y , Lot Number 19LBO181 ; CDS780202K , Lot Number 19BBF898 ; CDS780202K , Lot Number 19EBH536 ; CDS780202K , Lot Number 19EBW699 ; CDS780202K , Lot Number 19IBZ537 ; CDS780202K , Lot Number 19KBK182 ; CDS780202K , Lot Number 20BBE556 ; CDS780202K , Lot Number 20EBK692 ; CDS780202K , Lot Number 20HBD633 ; CDS780202K , Lot Number 20HBW511 ; CDS780202K , Lot Number 20IBM805 ; CDS780202K , Lot Number 20JBP710 ; CDS780202L , Lot Number 20KBL342 ; CDS780202L , Lot Number 21ABJ200 ; CDS780202L , Lot Number 21CBO838 ; CDS780202L , Lot Number 21DBH721 ; CDS780202L , Lot Number 21FBA775 ; CDS780202O , Lot Number 21KBK282 ; CDS780202P , Lot Number 22BMG694 ; CDS780202P , Lot Number 22BMH432 ; CDS780202P , Lot Number 22DME085 ; CDS780202P , Lot Number 22FMD852 ; CDS780202P , Lot Number 22FMH471 ; CDS780202P , Lot Number 22GME200 ; CDS780202P , Lot Number 22IMA512 ; CDS780202P , Lot Number 22IMA513 ; CDS780202P , Lot Number 22LMA065 ; CDS780202Q , Lot Number 22LMA225 ; CDS780202Q , Lot Number 23DME052 ; CDS780202Q , Lot Number 23EME852 ; CDS780202R , Lot Number 23FMI343 ; CDS780202R , Lot Number 23HMA280 ; CDS780202R , Lot Number 23HMF567 ; CDS780202R , Lot Number 23IMG471 ; CDS780202R , Lot Number 23LMG063 ; CDS780208D , Lot Number 19BBE281 ; CDS780208D , Lot Number 19CBW813 ; CDS780208D , Lot Number 19EBJ193 ; CDS780208D , Lot Number 19QBB506 ; CDS780208D , Lot Number 19FBY437 ; CDS780208D , Lot Number 19HBK572 ; CDS780208D , Lot Number 19JBU460 ; CDS780208D , Lot Number 20ABA580 ; CDS780208D , Lot Number 20DBF942 ; CDS780208D , Lot Number 20GBD855 ; CDS780208D , Lot Number 21ABD250 ; CDS780208F , Lot Number 22ABH903 ; CDS780208F , Lot Number 22BBQ627 ; CDS780208F , Lot Number 22DBL468 ; CDS780208F , Lot Number 22EBM543 ; CDS780208F , Lot Number 22HBH464 ; CDS780208F , Lot Number 22IBN540 ; CDS780208F , Lot Number 22KBM775 ; CDS780208F , Lot Number 23ABM574 ; CDS780208F , Lot Number 23ABU440 ; CDS780208F , Lot Number 21FBD429 ; CDS780230K, Lot Number 24CMH800; CDS780230K , Lot Number 21EME444 ; CDS780230K , Lot Number 21GMD475 ; CDS780230K , Lot Number 21HMG159 ; CDS780230K , Lot Number 22AMB644 ; CDS780230K , Lot Number 22AME418 ; CDS780230K , Lot Number 22CMB893 ; CDS780230K , Lot Number 22EMF683 ; CDS780230K , Lot Number 23BMF118 ; CDS780230K , Lot Number 23DMB891 ; CDS780230K , Lot Number 23DMG955 ; CDS780230K , Lot Number 23EMF336 ; CDS780230K , Lot Number 23EMG749 ; CDS780230K , Lot Number 23GMD696 ; CDS780230K , Lot Number 23HMF568 ; CDS780230K , Lot Number 24AME651 ; CDS780230K , Lot Number 19BKA866 ; CDS780230K , Lot Number 19DKB314 ; CDS780230K , Lot Number 19GKA073 ; CDS780230K , Lot Number 19IKC036 ; CDS780230K , Lot Number 20CKA869 ; CDS780230K , Lot Number 20EKB233 ; CDS780230K , Lot Number 20FKA792 ; CDS780230K , Lot Number 20HKA071 ; CDS780230K , Lot Number 20IKA278 ; CDS780230K , Lot Number 20IKA844 ; CDS780230K , Lot Number 20KKA255 ; CDS780230K , Lot Number 21CKA528 ; CDS840193U , Lot Number 19BBR999 ; CDS840193U , Lot Number 19GBF781 ; CDS840193U , Lot Number 19VBG349 ; CDS840193U , Lot Number 19LBI200 ; CDS840193U , Lot Number 19LBO263 ; CDS840193U , Lot Number 20DBT061 ; CDS840193U , Lot Number 20FBF962 ; CDS840193U , Lot Number 20GBG150 ; CDS840193U , Lot Number 20KBU635 ; CDS840193U , Lot Number 21BBD218 ; CDS980853N , Lot Number 19ADB477 ; CDS980853N , Lot Number 19BDC358 ; CDS980853N , Lot Number 19CDC680 ; CDS980853N , Lot Number 19DDA744 ; CDS980853N , Lot Number 19EDA991 ; CDS980853N , Lot Number 19FDD001 ; CDS980853N , Lot Number 19GDB395 ; CDS980853N , Lot Number 19KDA244 ; CDS980853N , Lot Number 20ADA320 ; CDS980853N , Lot Number 20BDA509 ; CDS980853N , Lot Number 20BDC708 ; CDS980853N , Lot Number 20DDB465 ; CDS980853N , Lot Number 20FDB972 ; CDS980853N , Lot Number 20GDC217 ; CDS981084K , Lot Number 19CKD398 ; CDS981084K , Lot Number 19EKB258 ; CDS981084L , Lot Number 19FKC140 ; CDS981084L , Lot Number 19HKB670 ; CDS981084L , Lot Number 19JKA279 ; CDS981084L , Lot Number 19KKB562 ; CDS981084L , Lot Number 19LKA703 ; CDS981084L , Lot Number 20AKA342 ; CDS981084L , Lot Number 20BKB585 ; CDS981084L , Lot Number 20DKB238 ; CDS981084L , Lot Number 20FKA822 ; CDS981084L , Lot Number 20GKB549 ; CDS981084M , Lot Number 21GMF555 ; CDS981084M , Lot Number 21JMA414 ; CDS981084M , Lot Number 21JMA828 ; CDS981084M , Lot Number 22AMC101 ; CDS981084M , Lot Number 22DMD672 ; CDS981084M , Lot Number 22DMF633 ; CDS981084M , Lot Number 22EMG544 ; CDS981084M , Lot Number 22GMA287 ; CDS981084M , Lot Number 22GMG418 ; CDS981084M , Lot Number 22JME525 ; CDS981084M , Lot Number 22KMD521 ; CDS981084M , Lot Number 23BME194 ; CDS981084M , Lot Number 23FMF210 ; CDS981084M , Lot Number 23GMH285 ; CDS981084M , Lot Number 23GMI042 ; CDS981084M , Lot Number 23KMD697 ; CDS981084M , Lot Number 20KKA032 ; CDS981084M , Lot Number 21BKA014 ; CDS981084M , Lot Number 21BKA347 ; CDS981084M , Lot Number 21CKB083 ; CDS981327N , Lot Number 19ABN030 ; CDS981327N , Lot Number 19DBH383 ; CDS981327N , Lot Number 19EBJ379 ; CDS981327N , Lot Number 19GBI961 ; CDS981327N , Lot Number 19HBU954 ; CDS981327N , Lot Number 19JBK986 ; CDS981327N , Lot Number 19LBW564 ; CDS981327N , Lot Number 20CBH905 ; CDS981327N , Lot Number 20EBS213 ; CDS981327N , Lot Number 20GBU395 ; CDS981327O , Lot Number 20JBO709 ; CDS981327O , Lot Number 20LBM343 ; CDS981327O , Lot Number 20LBM792 ; CDS981327O , Lot Number 21CBE183 ; CDS981327O , Lot Number 21DBJ732 ; CDS981327P , Lot Number 21KBO532 ; CDS981579N , Lot Number 19ABX923 ; CDS981579N , Lot Number 19CBK116 ; CDS981708K , Lot Number 19BKA...

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.

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