Recall archive / FDA device enforcement
Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-40... — FDA record Z-2997-2024
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) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ; 6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ; 7) AV FISTULA PACK , Pack Number CDS840188M ; 8) VP SHUNT, Pack Number CDS840193V ; 9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ; 10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ; 11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH; 12) CENTRAL LINE CDS, Pack Number CDS930092V ; 13) CENTRAL LINE CDS, Pack Number CDS930092W ; 14) CENTRAL LINE CDS, Pack Number CDS930092X ; 15) C LINE INSERTION CDS, Pack Number CDS980379I ; 16) C LINE INSERTION CDS, Pack Number CDS980379J ; 17) AV FISTULA - SMH, Pack Number CDS980916L ; 18) AV FISTULA CDS, Pack Number CDS981513G ; 19) VASCULAR ACCESS CDS , Pack Number CDS981552F ; 20) VP SHUNT CDS, Pack Number CDS981740G ; 21) VP SHUNT CDS, Pack Number CDS981740I ; 22) PORT A CATH , Pack Number CDS982047Q ; 23) SHY VP SHUNT CDS, Pack Number CDS982389J; 24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ; 25) A-V FISTULA , Pack Number CDS982637K ; 26) A-V FISTULA , Pack Number CDS982637L ; 27) VASCULAR TRAUMA , Pack Number CDS982641K ; 28) AV FISTULA CDS, Pack Number CDS982660G ; 29) AV FISTULA CDS, Pack Number CDS982660I ; 30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ; 31) AV FISTULA/ACCESS , Pack Number CDS983060I ; 32) AV FISTULA/ACCESS , Pack Number CDS983060J ; 33) AV SHUNT CDS, Pack Number CDS983098B ; 34) AV SHUNT CDS, Pack Number CDS983098C ; 35) VASCULAR ACCESS CDS , Pack Number CDS983105C ; 36) VP SHUNT, Pack Number CDS983366K ; 37) VP SHUNT, Pack Number CDS983366L ; 38) AV FISTULA, Pack Number CDS983638G ; 39) AV FISTULA, Pack Number CDS983638I ; 40) AV FISTULA, Pack Number CDS983638J ; 41) BARIATRIC CDS , Pack Number CDS983657J ; 42) BARIATRIC CDS , Pack Number CDS983657K ; 43) BARIATRIC CDS , Pack Number CDS983883C ; 44) GROTH AV FISTULA CDS, Pack Number CDS984191P ; 45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ; 46) GROTH AV FISTULA CDS, Pack Number CDS984191S ; 47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ; 48) GROTH LASER VEIN, Pack Number CDS984193R; 49) SHY AV FISTULA CDS, Pack Number CDS984512G ; 50) AV FISTULA, Pack Number CDS985510G ; 51) THORACOSTOMY TRAY , Pack Number CHT2010; 52) TRAUMA CHEST TUBE SET , Pack Number CHT2015; 53) BARD MYPICC$ KIT, Pack Number CK000234A; 54) BARD MYPICC$ KIT, Pack Number CK000236A; 55) BARD MYPICC$ KIT, Pack Number CK000324 ; 56) BARD MYPICC$ KIT, Pack Number CK000325 ; 57) BARD MYPICC$ KIT, Pack Number CK000645A; 58) BARD MYPICC$ KIT, Pack Number CK000646A; 59) BARD MYPICC$ KIT, Pack Number CK000647A; 60) BARD MYPICC$ KIT, Pack Number CK000713 ; 61) BARD MYPICC$ KIT, Pack Number CK000714 ; 62) CENTRAL LINE TRAY , Pack Number CVI4705; 63) CVC INSERTION PACK, Pack Number CVI4720; 64) ****, Pack Number CVI4720B...
- 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-2997-2024
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 | 00-401649G , Lot Number 19IMB453 ; 00-401649G , Lot Number 19KMA787 ; 00-401649G , Lot Number 19LMC950 ; 00-401649G , Lot Number 20EMA317 ; 00-401649G , Lot Number 20EMC074 ; 00-401649G , Lot Number 20HMA234 ; 00-401649G , Lot Number 20JME695 ; 00-401649G , Lot Number 20LME609 ; 00-401649G , Lot Number 21BME658 ; 00-401649G , Lot Number 21CMB025 ; 00-401649G , Lot Number 21CMD185 ; 00-401649G , Lot Number 21DMA102 ; 00-401649G , Lot Number 21JMA649 ; 00-401649G , Lot Number 21JMF121 ; 00-401649G , Lot Number 19BKC121 ; 00-401649G , Lot Number 19CKD014 ; 00-401649G , Lot Number 19EKA045 ; 00-401649G , Lot Number 19GKA016 ; 00-401649G , Lot Number 19HKB535 ; 00-401649G , Lot Number 19IKB266 ; 00-401993O , Lot Number 23JBF090 ; 00-401993O , Lot Number 23KBH528 ; 00-401993O , Lot Number 23LBO811 ; 00-402001T , Lot Number 21GBL509 ; 00-402001T , Lot Number 21JBN647 ; 00-402001T , Lot Number 21JBZ697 ; 00-402001T , Lot Number 22BBX248 ; 00-402001T , Lot Number 22DBL467 ; 00-402001T , Lot Number 22DBS962 ; 00-402001T , Lot Number 22GBC939 ; 00-402001T , Lot Number 22HBO291 ; 00-402001T , Lot Number 22HBO322 ; 00-402001T , Lot Number 22IBN444 ; 00-402001T , Lot Number 22IBO023 ; 00-402001T , Lot Number 22KBT315 ; 00-402001T , Lot Number 23BBA151 ; 00-402001T , Lot Number 23CBI235 ; 00-402001T , Lot Number 23DBM140 ; 00-402001T , Lot Number 23EBT729 ; 00-402001T , Lot Number 23GBR995 ; 00-402001T , Lot Number 23GBS336 ; 00-402001U , Lot Number 23JBU819 ; 00-402001U , Lot Number 23LBG449 ; A134-MAX , Lot Number 19BKA379 ; A134-MAX , Lot Number 19DKB704 ; A134-MAX , Lot Number 19HKA891 ; A134-MAX , Lot Number 19KKA912 ; A134-MAX , Lot Number 19KKB286 ; A134-MAX , Lot Number 19KKB345 ; A134-MAX , Lot Number 20BKA796 ; A134-MAX , Lot Number 20EKA291 ; A134-MAX , Lot Number 20FKA121 ; A134-MAX , Lot Number 20FKB492 ; ARTNC175 , Lot Number 24AMF171 ; CDS840188M , Lot Number 21GME281 ; CDS840188M , Lot Number 21HMG887 ; CDS840188M , Lot Number 21LMG878 ; CDS840188M , Lot Number 22DMC877 ; CDS840188M , Lot Number 22FMF061 ; CDS840188M , Lot Number 22HMA885 ; CDS840188M , Lot Number 22HMG503 ; CDS840188M , Lot Number 22LMC521 ; CDS840188M , Lot Number 23JMC244 ; CDS840188M , Lot Number 23LMH857 ; CDS840188M , Lot Number 19DKC523 ; CDS840188M , Lot Number 19FKB927 ; CDS840188M , Lot Number 19GKC786 ; CDS840188M , Lot Number 19IKA428 ; CDS840188M , Lot Number 19LKB624 ; CDS840188M , Lot Number 20CKA278 ; CDS840188M , Lot Number 20EKB674 ; CDS840188M , Lot Number 20GKA668 ; CDS840188M , Lot Number 20IKA403 ; CDS840188M , Lot Number 20LKB098 ; CDS840188M , Lot Number 21CKA368 ; CDS840193V , Lot Number 21HBE520 ; CDS840193V , Lot Number 21HBE521 ; CDS840193V , Lot Number 21HBH244 ; CDS840193V , Lot Number 21JBE527 ; CDS840193V , Lot Number 21KBE066 ; CDS840193V , Lot Number 22ABM907 ; CDS840193V , Lot Number 22MBA145 ; CDS840193V , Lot Number 22DBP331 ; CDS840193V , Lot Number 22EBM213 ; CDS840193V , Lot Number 22EBN031 ; CDS840193V , Lot Number 22EBR456 ; CDS840193V , Lot Number 22GBU281 ; CDS840193V , Lot Number 23DBO524 ; CDS840193V , Lot Number 23EBW686 ; CDS840193V , Lot Number 23FBO564 ; CDS840193V , Lot Number 23IBQ501 ; CDS840193V , Lot Number 23JBD094 ; CDS840193V , Lot Number 23JBW804 ; CDS840193V , Lot Number 23JBX015 ; CDS840193V , Lot Number 21FBC630 ; CDS840295G , Lot Number 21FBN182 ; CDS840295G , Lot Number 21HBB477 ; CDS840295G , Lot Number 21HBB479 ; CDS840295G , Lot Number 21IBK120 ; CDS840295G , Lot Number 21JBU314 ; CDS840295G , Lot Number 21LBO663 ; CDS840295G , Lot Number 22OBI226 ; CDS840295G , Lot Number 22OBL670 ; CDS840295G , Lot Number 22GBA989 ; CDS840295G , Lot Number 22GBA991 ; CDS840295G , Lot Number 22GBA994 ; CDS840295G , Lot Number 19RBD411 ; CDS840295G , Lot Number 22HBQ573 ; CDS840295G , Lot Number 22IBE716 ; CDS840295G , Lot Number 19IBD862 ; CDS840295G , Lot Number 19IBJ104 ; CDS840295G , Lot Number 19VBC474 ; CDS840295G , Lot Number 19WBA922 ; CDS840295G , Lot Number 20ABS649 ; CDS840295G , Lot Number 20BBE304 ; CDS840295G , Lot Number 20BBZ155 ; CDS840295G , Lot Number 20EBG194 ; CDS840295G , Lot Number 20FBV524 ; CDS840295G , Lot Number 20HBC285 ; CDS840295G , Lot Number 20JBH402 ; CDS840295G , Lot Number 21BBA694 ; CDS840295G , Lot Number 21BBE943 ; CDS840295G , Lot Number 21BBG966 ; CDS840295G , Lot Number 21DBG123 ; CDS860033A , Lot Number 22ABT263 ; CDS860033A , Lot Number 22BBM414 ; CDS860033A , Lot Number 19ABO084 ; CDS860033A , Lot Number 19ABV178 ; CDS860033A , Lot Number 19BBD349 ; CDS860033A , Lot Number 19CBL856 ; CDS860033A , Lot Number 22DBN148 ; CDS860033A , Lot Number 19DBJ620 ; CDS860033A , Lot Number 22FBW038 ; CDS860033A , Lot Number 22GBT020 ; CDS860033A , Lot Number 19HBB212 ; CDS860033A , Lot Number 22JBI775 ; CDS860033A , Lot Number 19TBB915 ; CDS860033A , Lot Number 22KBO931 ; CDS860033A , Lot Number 19JBJ664 ; CDS860033A , Lot Number 23ABH649 ; CDS860033A , Lot Number 23BBH056 ; CDS860033A , Lot Number 20BBJ471 ; CDS860033A , Lot Number 20BBM839 ; CDS860033A , Lot Number 20CBA321 ; CDS860033A , Lot Number 23FBT671 ; CDS860033A , Lot Number 23GBT005 ; CDS860033A , Lot Number 23HBC058 ; CDS860033A , Lot Number 20EBA004 ; CDS860033A , Lot Number 23HBV413 ; CDS860033A , Lot Number 20EBC143 ; CDS860033A , Lot Number 23JBI052 ; CDS860033A , Lot Number 20HBA540 ; CDS860033A , Lot Number 23KBV897 ; CDS860033A , Lot Number 20IBE893 ; CDS860033A , Lot Number 20IBG071 ; CDS860033A , Lot Number 24ABX646 ; CDS860033A , Lot Number 20JBS964 ; CDS860033A , Lot Number 20KBE285 ; CDS860033A , Lot Number 20LBU734 ; CDS860033A , Lot Number 21ABQ647 ; CDS860033A , Lot Number 21BBA695 ; CDS860033A , Lot Number 21BBJ404 ; CDS860033A , Lot Number 21BBO991 ; CDS860033A , Lot Number 21CBW001 ; CDS860033AH, Lot Number 22ABT263 ; CDS860033AH, Lot Number 22BBM414 ; CDS860033AH, Lot Number 19ABO084 ; CDS860033AH, Lot Number 19ABV178 ; CDS860033AH, Lot Number 19BBD349 ; CDS860033AH, Lot Number 19CBL856 ; CDS860033AH, Lot Number 22DBN148 ; CDS860033AH, Lot Number 19DBJ620 ; CDS860033AH, Lot Number 22FBW038 ; CDS860033AH, Lot Number 22GBT020 ; CDS860033AH, Lot Number 19HBB212 ; CDS860033AH, Lot Number 22JBI775 ; CDS860033AH, Lot Number 19TBB915 ; CDS860033AH, Lot Number 22KBO931 ; CDS860033AH, Lot Number 19JBJ664 ; CDS860033AH, Lot Number 23ABH649 ; CDS860033AH, Lot Number 23BBH056 ; CDS860033AH, Lot Number 23FBT671 ; CDS860033AH, Lot Number 23GBT005 ; CDS860033AH, Lot Number 23HBC058 ; CDS860033AH, Lot Number 23HBV413 ; CDS860033AH, Lot Number 23JBI052 ; CDS860033AH, Lot Number 23KBV897 ; CDS860033AH, Lot Number 24ABX646 ; CDS860033AH, Lot Number 21ABQ647 ; CDS860033AH, Lot Number 21BBA695 ; CDS860033AH, Lot Number 21BBJ404 ; CDS860033AH, Lot Number 21BBO991 ; CDS860033AH, Lot Number 21CBW001 ; CDS930092V , Lot Number 21BBB761 ; CDS930092V , Lot Number 21BBQ623 ; CDS930092W , Lot Number 21FBP631 ; CDS930092W , Lot Number 21GBV735 ; CDS930092W , Lot Number 21GBV736 ; CDS930092W , Lot Number 21IBE940 ; CDS930092W , Lot Number 21IBW823 ; CDS930092W , Lot Number 21JBU301 ; CDS930092W , Lot Number 22ABD356 ; CDS930092W , Lot Number 22OBB410 ; CDS930092W , Lot Number 22DBA742 ; CDS930092W , Lot Number 22FBS189 ; CDS930092W , Lot Number 21DBQ816 ; CDS930092X , Lot Number 22HBT776 ; CDS930092X , Lot Number 22HBU263 ; CDS930092X , Lot Number 22KBI026 ; CDS930092X , Lot Number 22KBI831 ; CDS930092X , Lot Number 23ABC352 ; CDS930092X , Lot Number 23CBX277 ; CDS930092X , Lot Number 23EBF083 ; CDS930092X , Lot Number 23EBL945 ; CDS930092X , Lot Number 23FBI837 ; CDS930092X , Lot Number 23HBO380 ; CDS930092X , Lot Number 23IBE351 ; CDS930092X , Lot Number 23IBN415 ; CDS930092X , Lot Number 23JBU793 ; CDS930092X , Lot Number 23KBW573 ; CDS930092X , Lot Number 24CBA853 ; CDS980379I , Lot Number 21JBA033 ; CDS980379I , Lot Number 21KBU590 ; CDS980379J , Lot Number 22ABD360 ; CDS980379J , Lot Number 22BBM228 ; CDS980379J , Lot Number 22EBS480 ; CDS980379J , Lot Number 22FBO274 ; CDS980379J , Lot Number 22GBZ054 ; CDS980379J , Lot Number 22IBC654 ; CDS980379J , Lot Number 22LBM746 ; CDS980379J , Lot Number 23ABB770 ; CDS980379J , Lot Number 23ABP535 ; CDS980379J , Lot Number 23EBC764 ; CDS980379J , Lot Number 23FBH022 ; CDS980379J , Lot Number 23HBD740 ; CDS980379J , Lot Number 23IBQ696 ; CDS980379J , Lot Number 23LBS839 ; CDS980379J , Lot Number 24BBE041 ; CDS980916L , Lot Number 21EBC082 ; CDS981513G , Lot Number 19FDB661 ; CDS981513G , Lot Number 19HDB466 ; CDS981513G , Lot Number 19IDA123 ; CDS981513G , Lot Number 19KDC365 ; CDS981513G , Lot Number 20GDA307 ; CDS981513G , Lot Number 20GDA958 ; CDS981513G , Lot Number 20IDA174 ; CDS981513G , Lot Number 20IDA815 ; CDS981513G , Lot Number 20IDB447 ; CDS981513G , Lot Number 21ADA966 ; CDS981513G , Lot Number 21LDC079 ; CDS981552F , Lot Number 21FBL049 ; CDS981552F , Lot Number 19BBN799 ; CDS981552F , Lot Number 19CBQ567 ; CDS981552F , Lot Number 19DBG524 ; CDS981552F , Lot Number 19FBW511 ; CDS981552F , Lot Number 19GBS783 ; CDS981552F , Lot Number 19HBU781 ; CDS981552F , Lot Number 20DBD797 ; CDS981552F , Lot Number 20FBB152 ; CDS981552F , Lot Number 20FBM682 ; CDS981552F , Lot Number 20JBO798 ; CDS981552F , Lot Number 21BBG842 ; CDS981552F , Lot Number 21DBJ790 ; CDS981552F , Lot Number 21EBI549 ; CDS981740G , Lot Number 19JBT846 ; CDS981740G , Lot Number 20ABE322 ; CDS981740G , Lot Number 20BBE594 ; CDS981740G , Lot Number 20DBF870 ; CDS981740G , Lot Number 20FBC072 ; CDS981740G , Lot Number 20HBC683 ; CDS981740G , Lot Number 20HBP054 ; CDS981740G , Lot Number 20HBQ757 ; CDS981740G , Lot Number 20JBQ386 ; CDS981740G , Lot Number 20LBL345 ; CDS981740G , Lot Number 20LBV734 ; CDS981740G , Lot Number 20LBW877 ; CDS981740I , Lot Number 21FBO491 ; CDS981740I , Lot Number 21GBJ341 ; CDS981740I , Lot Number 21IBT665 ; CDS981740I , Lot Number 21KBI181 ; CDS981740I , Lot Number 21LBB435 ; CDS981740I , Lot Number 21LBO595 ; CDS981740I , Lot Number 21LBO596 ; CDS981740I , Lot Number 22NBA990 ; CDS981740I , Lot Number 22CBV017 ; CDS981740I , Lot Number 22DBD191 ; CDS981740I , Lot Number 22DBG800 ; CDS981740I , Lot Number 22DBS548 ; CDS981740I , Lot Number 22EBK721 ; CDS981740I , Lot Number 22GBA960 ; CDS981740I , Lot Number 22HBF409 ; CDS981740I , Lot Number 21CBV552 ; CDS982047Q , Lot Number 21JDC632 ; CDS982047Q , Lot Number 21LDB376 ; CDS982047Q , Lot Number 22BDC332 ; CDS982047Q , Lot Number 22DDB499 ; CDS982047Q , Lot Number 22GDA026 ; CDS982047Q , Lot Number 22GDB948 ; CDS982047Q , Lot Number 22IDA166 ; CDS982047Q , Lot Number 22KDA648 ; CDS982047Q , Lot Number 23ADB084 ; CDS982047Q , Lot Number 23CDB665 ; CDS982047Q , Lot Number 23DDB432 ; CDS982047Q , Lot Number 23FDB743 ; CDS982047Q , Lot Number 23HDC294 ; CDS982047Q , Lot Number 23KDC271 ; CDS982389J, Lot Number 22IBU058; CDS982389J, Lot Number 22HBH306; CDS982389J, Lot Number 22GBQ912; CDS982389J, Lot Number 22DBT185; CDS982389J, Lot Number 22DBI063; CDS982524F , Lot Number 19BKC881 ; CDS982524F , Lot Number 19CKD408 ; CDS982524F , Lot Number 19EKB530 ; CDS982524F , Lot Number 19FKC305 ; CDS982524F , Lot Number 19HKC284 ; CDS982524F , Lot Number 19IKC091 ; CDS982524F , Lot Number 19JKB737 ; CDS982524F , Lot Number 20AKB430 ; CDS982524F , Lot Number 20FKA087 ; CDS982524F , Lot Number 20GKA301 ; CDS982524F , Lot Number 20HKA846 ; CDS982637K , Lot Number 19CBG888 ; CDS982637K , Lot Number 19EBI583 ; CDS982637K , Lot Number 19QBC134 ; CDS982637K , Lot Number 19GBF246 ; CDS982637K , Lot Number 19TBD282 ; CDS982637K , Lot Number 19VBE086 ; CDS982637K , Lot Number 20ABJ943 ; CDS982637K , Lot Number 20BBO077 ; CDS982637K , Lot Number 20CBP500 ; CDS982637K , Lot Number 20EBG501 ; CDS982637K , Lot Number 20EBJ947 ; CDS982637K , Lot Number 20FBE041 ; CDS982637K , Lot Number 21ABE728 ; CDS982637K , Lot Number 21ABT649 ; CDS982637L , Lot Number 21FBP626 ; CDS982637L , Lot Number 21GBV693 ; CDS982637L , Lot Number 21HBF202 ; CDS982637L , Lot Number 21LBJ738 ; CDS982637L , Lot Number 22ABA355 ; CDS982637L , Lot Number 22BBE738 ; CDS982637L , Lot Number 22BBR730 ; CDS982637L , Lot Number ... |
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.