Recall archive / FDA device enforcement
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pac... — FDA record Z-2998-2024
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) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Number 00-400832O ; 6) BIOPSY PROCEDURE PACK , Pack Number 00-400832P ; 7) BIOPSY PROCEDURE PACK , Pack Number 00-401261F ; 8) 6" FEMORAL ARTERIALLINE KIT, Pack Number ART245B; 9) BREAST BIOPSY KIT , Pack Number BT1085A; 10) BREAST BIOPSY PROCEDURE TRAY, Pack Number BX8375F; 11) BREAST/MINOR, Pack Number CDS980228X ; 12) BIOPSY CDS-LF , Pack Number CDS984667D ; 13) BIOPSY CDS-LF , Pack Number CDS984667F ; 14) BREAST-HERNIA-PORT CDS-LF , Pack Number CDS984853G ; 15) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 16) QSUM STEREO/US BIOPSY TRAY, Pack Number CT101; 17) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960; 18) BIOPSY DEKALB PACK, Pack Number DM150A ; 19) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 20) COLONOSCOPY KIT , Pack Number DYKE1218 ; 21) BREAST BIOPSY KIT , Pack Number DYNDA1224B ; 22) TDC REMOVAL, Pack Number DYNDA1633A; 23) BREAST BIOPSY PACK, Pack Number DYNDA2378A ; 24) CUSTOM BIOPSY TRAY, Pack Number DYNDA2448; 25) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 26) BIOPSY/MYELOGRAM PACK, Pack Number DYNDA2655; 27) PICU LINE TRAY, Pack Number DYNDC1960A; 28) PORT ACCESS KIT, Pack Number DYNDC2945; 29) CT BIOPSY TRAY, Pack Number DYNDH1054; 30) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 31) BIOPSY PACK , Pack Number DYNDH1110; 32) ARTHROGRAM TRAY, Pack Number DYNDH1113; 33) BIOPSY TRAY , Pack Number DYNDH1114; 34) BIOPSY TRAY, Pack Number DYNDH1129; 35) ARTHROGRAM TRAY, Pack Number DYNDH1134; 36) BIOPSY PACK , Pack Number DYNDH1137A ; 37) BREAST BIOPSY TRAY, Pack Number DYNDH1142C ; 38) BREAST BIOPSY TRAY, Pack Number DYNDH1152A ; 39) BIOPSY KIT, Pack Number DYNDH1156; 40) ULTRASOUND TRAY, Pack Number DYNDH1204; 41) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 42) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 43) CORE BIOPSY TRAY, Pack Number DYNDH1233; 44) BIOPSY PACK, Pack Number DYNDH1248; 45) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 46) BREAST BIOPSY TRAY, Pack Number DYNDH1266; 47) GENERAL BIOPSY TRAY , Pack Number DYNDH1268; 48) BIOPSY TRAY, Pack Number DYNDH1269; 49) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 50) DB CT BIOPSY TRAY -LF , Pack Number DYNDH1270; 51) BIOPSY TRAY , Pack Number DYNDH1273; 52) BIOPSY PACK TAA COMPLIANT , Pack Number DYNDH1294; 53) BREAST BIOPSY TRAY, Pack Number DYNDH1296B ; 54) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 55) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 56) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 57) BREAST BIOPSY TRAY, Pack Number DYNDH1302; 58) BREAST BIOPSY TRAY, Pack Number DYNDH1302H ; 59) BIOPSY TRAY, Pack Number DYNDH1314; 60) BIOPSY TRAY , Pack Number DYNDH1314A ; 61) MAMMOGRAPHY BREAST BIOPSY, Pack Number DYNDH1318; 62) ULTRASOUND GUIDE BREAST BIOPSY, Pack N...
- 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-2998-2024
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 | 00-400162J, Lot Number 24BMJ154; 00-400162J , Lot Number 21HBM269 ; 00-400162J , Lot Number 21IBK734 ; 00-400162J , Lot Number 21VBB786 ; 00-400162J , Lot Number 21KBS936 ; 00-400162J , Lot Number 21LBA763 ; 00-400162J , Lot Number 22ABN222 ; 00-400162J , Lot Number 19ABM483 ; 00-400162J , Lot Number 19BBI451 ; 00-400162J , Lot Number 19CBM173 ; 00-400162J , Lot Number 19DBL959 ; 00-400162J , Lot Number 22FBO944 ; 00-400162J , Lot Number 19FBG533 ; 00-400162J , Lot Number 22JBB402 ; 00-400162J , Lot Number 19TBB201 ; 00-400162J , Lot Number 22KBV632 ; 00-400162J , Lot Number 19JBD745 ; 00-400162J , Lot Number 19KBI828 ; 00-400162J , Lot Number 19LBK452 ; 00-400162J , Lot Number 23CBO907 ; 00-400162J , Lot Number 19LBY367 ; 00-400162J , Lot Number 20ABQ389 ; 00-400162J , Lot Number 23FBG349 ; 00-400162J , Lot Number 20CBV380 ; 00-400162J , Lot Number 20DBI320 ; 00-400162J , Lot Number 23IBF372 ; 00-400162J , Lot Number 20FBQ675 ; 00-400162J , Lot Number 20GBO378 ; 00-400162J , Lot Number 20JBH095 ; 00-400162J , Lot Number 20JBL452 ; 00-400162J , Lot Number 20JBX151 ; 00-400162J , Lot Number 20KBZ223 ; 00-400162J , Lot Number 20XBA215 ; 00-400162J , Lot Number 21DBB680 ; 00-400162J , Lot Number 24AMB898 ; 00-400405C , Lot Number 21KBM812 ; 00-400405C , Lot Number 21LBT408 ; 00-400405C , Lot Number 21LBT899 ; 00-400405C , Lot Number 19ABL059 ; 00-400405C , Lot Number 19BBB783 ; 00-400405C , Lot Number 19CBC868 ; 00-400405C , Lot Number 19KBY105 ; 00-400405C , Lot Number 19LBB184 ; 00-400762H , Lot Number 21HBR227 ; 00-400832N , Lot Number 19BDA790 ; 00-400832N , Lot Number 19BDD147 ; 00-400832N , Lot Number 19DDB220 ; 00-400832N , Lot Number 19FDA964 ; 00-400832O , Lot Number 19IDA318 ; 00-400832O , Lot Number 19KMA743 ; 00-400832O , Lot Number 19KMC836 ; 00-400832O , Lot Number 20BMA017 ; 00-400832O , Lot Number 20CMB031 ; 00-400832O , Lot Number 20FMB526 ; 00-400832O , Lot Number 20HMC867 ; 00-400832O , Lot Number 20JMB320 ; 00-400832O , Lot Number 21AMC858 ; 00-400832O , Lot Number 21FMA865 ; 00-400832O , Lot Number 21HMB368 ; 00-400832O , Lot Number 21JMA868 ; 00-400832O , Lot Number 22AME715 ; 00-400832O , Lot Number 22CMA957 ; 00-400832P , Lot Number 23LBL872 ; 00-400832P , Lot Number 22EMF901 ; 00-400832P , Lot Number 22GMD199 ; 00-400832P , Lot Number 22HME947 ; 00-400832P , Lot Number 22JMA494 ; 00-400832P , Lot Number 22KMD610 ; 00-400832P , Lot Number 23AMB199 ; 00-400832P , Lot Number 23CMD961 ; 00-400832P , Lot Number 23EMD513 ; 00-400832P , Lot Number 23FMH541 ; 00-400832P , Lot Number 23GMH251 ; 00-400832P , Lot Number 23IMA234 ; 00-400832P , Lot Number 23KMA301 ; 00-401261F , Lot Number 19DDD151 ; ART245B, Lot Number 2023050490; BT1085A, Lot Number 21JBW716 ; BT1085A, Lot Number 22EBN971 ; BT1085A, Lot Number 22IBO409 ; BT1085A, Lot Number 22KBQ151 ; BT1085A, Lot Number 22LBS928 ; BT1085A, Lot Number 23EBQ469 ; BT1085A, Lot Number 23HBA899 ; BT1085A, Lot Number 23HBM503 ; BT1085A, Lot Number 23LBP500 ; BX8375F, Lot Number 19BBQ976 ; CDS980228X , Lot Number 21IBJ198 ; CDS980228X , Lot Number 21IBL102 ; CDS980228X , Lot Number 21IBT611 ; CDS980228X , Lot Number 21KBA518 ; CDS980228X , Lot Number 22CBT672 ; CDS980228X , Lot Number 22OBL706 ; CDS980228X , Lot Number 22EBN150 ; CDS980228X , Lot Number 22GBJ007 ; CDS980228X , Lot Number 22GBJ522 ; CDS980228X , Lot Number 22GBU493 ; CDS980228X , Lot Number 22HBO646 ; CDS980228X , Lot Number 22JBH336 ; CDS980228X , Lot Number 22KBI846 ; CDS980228X , Lot Number 23BBB687 ; CDS980228X , Lot Number 23BBB770 ; CDS980228X , Lot Number 23CBQ216 ; CDS980228X , Lot Number 23EBG155 ; CDS980228X , Lot Number 23FBH110 ; CDS980228X , Lot Number 23FBU678 ; CDS980228X , Lot Number 23HBK342 ; CDS980228X , Lot Number 23IBM309 ; CDS980228X , Lot Number 23KBN911 ; CDS980228X , Lot Number 23LBQ885 ; CDS980228X , Lot Number 24ABV909 ; CDS984667D , Lot Number 19ABX202 ; CDS984667D , Lot Number 19CBJ247 ; CDS984667D , Lot Number 19EBK219 ; CDS984667D , Lot Number 19GBH803 ; CDS984667D , Lot Number 19HBM191 ; CDS984667D , Lot Number 19KBR426 ; CDS984667D , Lot Number 20BBD375 ; CDS984667D , Lot Number 20BBW882 ; CDS984667D , Lot Number 20FBL632 ; CDS984667D , Lot Number 20HBI802 ; CDS984667D , Lot Number 20JBH644 ; CDS984667D , Lot Number 21ABW316 ; CDS984667D , Lot Number 21BBO832 ; CDS984667F , Lot Number 21HBI147 ; CDS984667F , Lot Number 21HBQ079 ; CDS984667F , Lot Number 21IBC923 ; CDS984667F , Lot Number 21JBC107 ; CDS984667F , Lot Number 21JBM708 ; CDS984667F , Lot Number 21LBG294 ; CDS984667F , Lot Number 22NBF721 ; CDS984667F , Lot Number 22OBJ844 ; CDS984667F , Lot Number 21EBC591 ; CDS984667F , Lot Number 22FMH829 ; CDS984667F , Lot Number 22HMA231 ; CDS984667F , Lot Number 22JMB506 ; CDS984667F , Lot Number 22JMG035 ; CDS984667F , Lot Number 22KMC059 ; CDS984667F , Lot Number 22LME009 ; CDS984667F , Lot Number 23AMF563 ; CDS984667F , Lot Number 23CMD811 ; CDS984667F , Lot Number 23CMG538 ; CDS984667F , Lot Number 23FMC037 ; CDS984667F , Lot Number 23GMA593 ; CDS984853G , Lot Number 21JDB293 ; CDS984853G , Lot Number 21KDB427 ; CDS984853G , Lot Number 21LDA306 ; CIT6785A, Lot Number 2021111990; CT101, Lot Number 22HBM599; CT101, Lot Number 22GBL378; CT101, Lot Number 22FBU522; CT101, Lot Number 22CBV047; CT101, Lot Number 22BBP535; CT101, Lot Number 21HBC220; CVI4960, Lot Number 2023061490; DM150A , Lot Number 19ABE922 ; DM150A , Lot Number 19ABI891 ; DM150A , Lot Number 19CBE170 ; DM150A , Lot Number 19CBL567 ; DM150A , Lot Number 19DBU214 ; DM150A , Lot Number 19GBA025 ; DM150A , Lot Number 19GBZ648 ; DM150A , Lot Number 19IBM291 ; DM150A , Lot Number 20BBY500 ; DM150A , Lot Number 20DBC998 ; DM150A , Lot Number 20EBJ718 ; DM150A , Lot Number 20GBK855 ; DM150A , Lot Number 20HBD401 ; DM150A , Lot Number 20KBC120 ; DM150A , Lot Number 20XBD159 ; DM645, Lot Number 2019090380; DYKE1218 , Lot Number 21LMG689 ; DYNDA1224B , Lot Number 23KMG399 ; DYNDA1633A, Lot Number 2021070650; DYNDA2378A , Lot Number 21JBR470 ; DYNDA2448, Lot Number 21JBC950 ; DYNDA2497, Lot Number 2019060550; DYNDA2497, Lot Number 2019062050; DYNDA2655, Lot Number 22OBC046; DYNDA2655, Lot Number 22CBX719; DYNDA2655, Lot Number 22DBB515 ; DYNDA2655, Lot Number 23EBK488 ; DYNDA2655, Lot Number 23EBR534 ; DYNDA2655, Lot Number 23FBK774 ; DYNDA2655, Lot Number 23GBD758 ; DYNDA2655, Lot Number 23GBQ973 ; DYNDA2655, Lot Number 23IBJ592 ; DYNDA2655, Lot Number 24ABC341 ; DYNDC1960A, Lot Number 2019062050; DYNDC2945, Lot Number 2022092990; DYNDH1054, Lot Number 2018071250; DYNDH1108, Lot Number 21IBS645 ; DYNDH1108, Lot Number 21JBY809 ; DYNDH1108, Lot Number 22BBG422 ; DYNDH1108, Lot Number 19ABR481 ; DYNDH1108, Lot Number 19DBI234 ; DYNDH1108, Lot Number 19EBL436 ; DYNDH1108, Lot Number 19EBL551 ; DYNDH1108, Lot Number 20CBU457 ; DYNDH1108, Lot Number 20GBI404 ; DYNDH1108, Lot Number 20JBI282 ; DYNDH1108, Lot Number 20KBT996 ; DYNDH1108, Lot Number 21ABS179 ; DYNDH1108, Lot Number 21CBV898 ; DYNDH1108, Lot Number 21DBG359 ; DYNDH1108, Lot Number 21EBQ401 ; DYNDH1108, Lot Number 22CMC304 ; DYNDH1108, Lot Number 22EMI535 ; DYNDH1108, Lot Number 22FMG345 ; DYNDH1108, Lot Number 22JME999 ; DYNDH1108, Lot Number 23BMA505 ; DYNDH1108, Lot Number 23DMD916 ; DYNDH1108, Lot Number 23EMH904 ; DYNDH1108, Lot Number 23FMD384 ; DYNDH1108, Lot Number 23FMI958 ; DYNDH1108, Lot Number 23IMI347 ; DYNDH1108, Lot Number 23JMH539 ; DYNDH1108, Lot Number 23LMB050 ; DYNDH1110, Lot Number 21JBI819 ; DYNDH1113, Lot Number 2019100950; DYNDH1114, Lot Number 21JBQ576 ; DYNDH1129, Lot Number 2018061450; DYNDH1129, Lot Number 2019011450; DYNDH1129, Lot Number 2019062050; DYNDH1129, Lot Number 2019080250; DYNDH1129, Lot Number 2019100150; DYNDH1134, Lot Number 2018091050; DYNDH1137A , Lot Number 19CBQ763 ; DYNDH1142C , Lot Number 21KBT970 ; DYNDH1142C , Lot Number 22BBG396 ; DYNDH1142C , Lot Number 21CBL686 ; DYNDH1142C , Lot Number 21CBM797 ; DYNDH1142C , Lot Number 22FMA927 ; DYNDH1142C , Lot Number 23AMJ692 ; DYNDH1142C , Lot Number 23CMA358 ; DYNDH1142C , Lot Number 23DMC945 ; DYNDH1142C , Lot Number 23FMF669 ; DYNDH1142C , Lot Number 23KMA966 ; DYNDH1142C , Lot Number 23LMB042 ; DYNDH1152A , Lot Number 21JBM609 ; DYNDH1156, Lot Number 21JBR523 ; DYNDH1204, Lot Number 2018062950; DYNDH1227A, Lot Number 2019050890; DYNDH1227B, Lot Number 2022021190; DYNDH1227B , Lot Number 20FBK116 ; DYNDH1227B , Lot Number 20HBB805 ; DYNDH1227B , Lot Number 20IBF887 ; DYNDH1233, Lot Number 21JBP011 ; DYNDH1248, Lot Number 2018071850; DYNDH1257, Lot Number 2019011450; DYNDH1257, Lot Number 2019021850; DYNDH1257, Lot Number 2019092450; DYNDH1257, Lot Number 2019101450; DYNDH1257, Lot Number 2019110450; DYNDH1266, Lot Number 21JBR760 ; DYNDH1268, Lot Number 21JBR420 ; DYNDH1269, Lot Number 2018061450; DYNDH1269, Lot Number 2020012350; DYNDH1269, Lot Number 22GBP946 ; DYNDH1269, Lot Number 22IBH093 ; DYNDH1269, Lot Number 23BBI257 ; DYNDH1269, Lot Number 23DBK823 ; DYNDH1269, Lot Number 23GBA153 ; DYNDH1269, Lot Number 23JBJ925 ; DYNDH1269, Lot Number 24ABW151 ; DYNDH1270, Lot Number 2019031490; DYNDH1270, Lot Number 2019050890; DYNDH1270, Lot Number 2019072290; DYNDH1270, Lot Number 21IBG275 ; DYNDH1270, Lot Number 21IBG292 ; DYNDH1270, Lot Number 21IBG556 ; DYNDH1270, Lot Number 21LBS564 ; DYNDH1270, Lot Number 22DBA102 ; DYNDH1270, Lot Number 22EBN016 ; DYNDH1270, Lot Number 19HBK811 ; DYNDH1270, Lot Number 22JBH169 ; DYNDH1270, Lot Number 22KBP080 ; DYNDH1270, Lot Number 22KBU728 ; DYNDH1270, Lot Number 23CBN975 ; DYNDH1270, Lot Number 20ABJ527 ; DYNDH1270, Lot Number 23EBP053 ; DYNDH1270, Lot Number 20BBY926 ; DYNDH1270, Lot Number 20BBZ444 ; DYNDH1270, Lot Number 20CBB656 ; DYNDH1270, Lot Number 23HBX369 ; DYNDH1270, Lot Number 20FBB439 ; DYNDH1270, Lot Number 23JBP702 ; DYNDH1270, Lot Number 23KBH402 ; DYNDH1270, Lot Number 20HBA149 ; DYNDH1270, Lot Number 20JBP109 ; DYNDH1270, Lot Number 20LBU089 ; DYNDH1270, Lot Number 21ABN463 ; DYNDH1270, Lot Number 21BBO653 ; DYNDH1270, Lot Number 21CBZ193 ; DYNDH1270, Lot Number 21EBQ153 ; DYNDH1273, Lot Number 20CBF416 ; DYNDH1273, Lot Number 20EBS909 ; DYNDH1273, Lot Number 20FBW150 ; DYNDH1273, Lot Number 20HBQ625 ; DYNDH1273, Lot Number 20IBC072 ; DYNDH1294, Lot Number 21JBZ911 ; DYNDH1294, Lot Number 22FME565 ; DYNDH1294, Lot Number 22HMG282 ; DYNDH1294, Lot Number 23BMA464 ; DYNDH1294, Lot Number 23BMG476 ; DYNDH1294, Lot Number 23HMF973 ; DYNDH1294, Lot Number 23JMA389 ; DYNDH1294, Lot Number 23JMF679 ; DYNDH1296B , Lot Number 21JBK568 ; DYNDH1297, Lot Number 2019060550; DYNDH1297, Lot Number 22GBO343 ; DYNDH1297, Lot Number 22JBI828 ; DYNDH1297, Lot Number 22LBK229 ; DYNDH1297, Lot Number 23EBI256 ; DYNDH1297, Lot Number 23GBE050 ; DYNDH1297, Lot Number 23LBQ777 ; DYNDH1300, Lot Number 2018061450; DYNDH1302, Lot Number 21JBQ374 ; DYNDH1302H , Lot Number 21JBQ374 ; DYNDH1314, Lot Number 2018052950; DYNDH1314, Lot Number 2018071850; DYNDH1314, Lot Number 2018080250; DYNDH1314, Lot Number 2018081550; DYNDH1314A , Lot Number 19CAB562 ; DYNDH1318, Lot Number 2019011050; DYNDH1319, Lot Number 2018102650; DYNDH1324, Lot Number 2019011850; DYNDH1328, Lot Number 22HMA359; DYNDH1328, Lot Number 22FME915; DYNDH1328, Lot Number 22DMA781; DYNDH1328, Lot Number 21JBN313 ; DYNDH1328, Lot Number 23JMJ203 ; DYNDH1328, Lot Number 23KMH462 ; DYNDH1328, Lot Number 23LMF075 ; DYNDH1355A , Lot Number 19BAB620 ; DYNDH1355A , Lot Number 19DAA066 ; DYNDH1355A , Lot Number 19DAB614 ; DYNDH1355A , Lot Number 19EAB062 ; DYNDH1355A , Lot Number 19FAB229 ; DYNDH1376A , Lot Number 21JBF339 ; DYNDH1425, Lot Number 21JBI203 ; DYNDH1430A , Lot Number 23GBF746 ; DYNDH1430A , Lot Number 23HBV750 ; DYNDH1434, Lot Number 21FBO653 ; DYNDH1434, Lot Number 21KBH014 ; DYNDH1434, Lot Number 21LBB156 ; DYNDH1434, Lot Number 22ABJ623 ; DYNDH1434, Lot Number 22ABK656 ; DYNDH1434, Lot Number 23GBI830 ; DYNDH1434, Lot Number 20JBP719 ; DYNDH1434, Lot Number 21BBE028 ; DYNDH1434, Lot Number 21EBO430 ; DYNDH1477, Lot Number 21HBR113 ; DYNDH1477, Lot Number 21VBD398 ; DYNDH1477, Lot Number 22DBD051 ; DYND... |
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.