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RecallWatchMedical Device Safety
Class IIOngoingZ-1438-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) AV FISTULA PACK

MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesReported Apr 2, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C; 6) CARDIAC CATH PACK, Pack Number DYNJ61256A; 7) CARDIAC CATH PACK-LF, Pack Number DYNJ61527; 8) CARDIAC CATH PACK-LF, Pack Number DYNJ53642C; 9) CARDIOVASCULAR PACK LJ-LF, Pack Number DYNJ49635F; 10) CAROTID PACK, Pack Number DYNJ0810062AI; 11) CASTRO CABG-COMPONENT PACK, Pack Number DYNJ44857T; 12) CATH PACK, Pack Number DYNJ59830A; 13) CHOG CARDIAC CATH PACK, Pack Number SYNJ10304B; 14) CICC, Pack Number DYNJ53854A; 15) CMHP PACEMAKER PACK, Pack Number DYNJ30217G; 16) DR NACKMAN VEIN PACK, Pack Number DYNJ56235; 17) ENDOVASCULAR AAA PACK-LF, Pack Number DYNJ55482F; 18) EP DEVICE, Pack Number DYNJ65916B; 19) EP STUDY PACK-LF, Pack Number DYNJ38059A; 20) FHZ PACEMAKER PACK, Pack Number DYNJ36931D; 21) GV OPEN HEART PACK, Pack Number DYNJ60618C; 22) HEART CABG CDS, Pack Number CDS983376Q; 23) HEART DRAPE & SUPPLY PACK, Pack Number DYNJ65226; 24) HH ARTERIOGRAM PACK, Pack Number DYNJ59466A; 25) LEX OPEN HEART, Pack Number DYNJ900968I; 26) MAJOR VASCULAR PACK SAFETY, Pack Number DYNJ54738C; 27) NIR PACK, Pack Number DYNJ63892A; 28) OPEN HEART, Pack Number DYNJ904261B; 29) OPEN HEART, Pack Number DYNJ904261B; 30) OPEN HEART, Pack Number DYNJ905021J; 31) OPEN HEART A PACK, Pack Number DYNJ04478R; 32) OPEN HEART ACC, Pack Number DYNJ23533D; 33) OPEN HEART CDS, Pack Number CDS840171AB; 34) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048N; 35) OPEN HEART PACK, Pack Number DYNJ45122C; 36) OPEN HEART PACK, Pack Number DYNJ55648; 37) OPEN HEART PACK, Pack Number DYNJ04381J; 38) OPEN HEART PACK & BASIN SET-LF, Pack Number DYNJ24300M; 39) OPEN HEART PACK-LF, Pack Number DYNJ0369758N; 40) OPEN HEART PART B PACK, Pack Number DYNJ43038N; 41) OPEN HEART SUPPLY, Pack Number DYNJ65641; 42) OPEN PACK, Pack Number DYNJ67442B; 43) PACEMAKER, Pack Number DYNJ59399I; 44) PACEMAKER IMPLANT PACK-LF, Pack Number DYNJ0373237M; 45) PACEMAKER PACK, Pack Number DYNJ66165; 46) PACEMAKER PACK, Pack Number DYNJ41134B; 47) PACEMAKER PACK, Pack Number DYNJ61260A; 48) PACEMAKER PACK, Pack Number DYNJ60635; 49) PACEMAKER PACK, Pack Number DYNJ42602C; 50) PACEMAKER PACK 0121271-LF, Pack Number DYNJ32897J; 51) PACEMAKER PACK CV-LF, Pack Number DYNJ39912B; 52) PACEMAKER PACK-LF, Pack Number DYNJ53112B; 53) PACEMAKER PACK-LF, Pack Number DYNJ51844B; 54) PACEMAKER PACK-LF, Pack Number DYNJ0854874R; 55) PEDI EP PACK, Pack Number DYNJ54750G; 56) PERMANENT PACING PACK-LF, Pack Number DYNJ22036F; 57) PK, OPEN HEART, Pack Number DYNJ44015B; 58) PK, OPEN HEART-CABG, Pack Number DYNJ45048C; 59) RR-ADULT PUMP PACK-LF, Pack Number DYNJ0394805N; 60) RRMC CAROTID PACK-2, Pack Number DYNJ33544L; 61) RR-PEDIATRIC PUMP PACK-LF, Pack Number DYNJ0394730P; 62) TAVR PACK, Pack Number DYNJ58386A; 63) THORACIC PACK, Pack Number DYNJ80309; 64) VASCULAR, Pack Number DYNJ45376G; 65) VASCULAR PACK, Pack Number DYNJ48288C; 66) VASCULAR PACK, Pack Number DYNJ54979; 67) VASCULAR PACK, Pack Number DYNJ64883C; 68) VASCULAR PACK, Pack Number DYNJ43945I; 69) VASCULAR PACK, Pack Number DYNJ43945I; 70) VASCULAR PACK, Pack Number DYNJ67426A; 71) VASCULAR PACK WRO-LF, Pack Number DYNJ41863C; 72) VASCULAR SUB, Pack Number DYNJ60681A; 73) VASCULAR SUB, Pack Number DYNJ60681A

Lot / code information

Lot #
23DBG477A; 2) Pack Number DYNJ0131782J: UDI/DI 10195327467548 (each) 40195327467549 (case)
Lot #
23LMD975A; 3) Pack Number DYNJ906462B: UDI/DI 10195327057886 (each) 40195327057887 (case)
Lot #
22GBV822Z; 4) Pack Number DYNJ0261346U: UDI/DI 10195327055967 (each) 40195327055968 (case)
Lot #
22GMB113A; 5) Pack Number DYNJ42997C: UDI/DI 10193489988420 (each) 40193489988421 (case)
Lot #
21JMG551A; 6) Pack Number DYNJ61256A: UDI/DI 10193489694918 (each) 40193489694919 (case)
Lot #
23JBH403A; 7) Pack Number DYNJ61527: UDI/DI 10193489578881 (each) 40193489578882 (case)
Lot #
21LBJ158A; 8) Pack Number DYNJ53642C: UDI/DI 10193489721607 (each) 40193489721608 (case)
Lot #
24AMF039A; 9) Pack Number DYNJ49635F: UDI/DI 10195327191405 (each) 40195327191406 (case)
Lot #
23LMF122A; 10) Pack Number DYNJ0810062AI: UDI/DI 10193489866049 (each) 40193489866040 (case)
Lot #
22CMB582A; 11) Pack Number DYNJ44857T: UDI/DI 10195327221959 (each) 40195327221950 (case)
Show 63 more code fields
Lot #
22JBD481Z; 12) Pack Number DYNJ59830A: UDI/DI 10193489570236 (each) 40193489570237 (case)
Lot #
21EMF434A; 13) Pack Number SYNJ10304B: UDI/DI 10193489786965 (each) 40193489786966 (case)
Lot #
21LBD584A; 14) Pack Number DYNJ53854A: UDI/DI 10193489631517 (each) 40193489631518 (case)
Lot #
21GMB561A; 15) Pack Number DYNJ30217G: UDI/DI 10193489922141 (each) 40193489922142 (case)
Lot #
23CBN679A; 16) Pack Number DYNJ56235: UDI/DI 10889942621552 (each) 40889942621553 (case)
Lot #
23EBD843A; 17) Pack Number DYNJ55482F: UDI/DI 10195327332273 (each) 40195327332274 (case)
Lot #
23BBS877A; 18) Pack Number DYNJ65916B: UDI/DI 10193489902044 (each) 40193489902045 (case)
Lot #
23JBT190A; 19) Pack Number DYNJ38059A: UDI/DI 10193489401110 (each) 40193489401111 (case)
Lot #
20LMF803A; 20) Pack Number DYNJ36931D: UDI/DI 10193489927559 (each) 40193489927550 (case)
Lot #
23BBS364Z; 21) Pack Number DYNJ60618C: UDI/DI 10193489475630 (each) 40193489475631 (case)
Lot #
22GMD148Z; 22) Pack Number CDS983376Q: UDI/DI 10195327379797 (each) 40195327379798 (case)
Lot #
23IBG370Z; 23) Pack Number DYNJ65226: UDI/DI 10193489253672 (each) 40193489253673 (case)
Lot #
20BDA909A; 24) Pack Number DYNJ59466A: UDI/DI 10193489562613 (each) 40193489562614 (case)
Lot #
21BBF996A; 25) Pack Number DYNJ900968I: UDI/DI 10193489453188 (each) 40193489453189 (case)
Lot #
22IBM300N; 26) Pack Number DYNJ54738C: UDI/DI 10193489778755 (each) 40193489778756 (case)
Lot #
21EBF317A; 27) Pack Number DYNJ63892A: UDI/DI 10195327176518 (each) 40195327176519 (case)
Lot #
23LME320A; 28) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case)
Lot #
22IBN057Z; 29) Pack Number DYNJ904261B: UDI/DI 10193489479539 (each) 40193489479530 (case)
Lot #
22JBJ452Z; 30) Pack Number DYNJ905021J: UDI/DI 10195327281625 (each) 40195327281626 (case)
Lot #
23DBI088Z; 31) Pack Number DYNJ04478R: UDI/DI 10888277748835 (each) 40888277748836 (case)
Lot #
22GMA554A; 32) Pack Number DYNJ23533D: UDI/DI 10193489470659 (each) 40193489470650 (case)
Lot #
22GMC009A; 33) Pack Number CDS840171AB: UDI/DI 10195327167042 (each) 40195327167043 (case)
Lot #
22GMG011Z; 34) Pack Number DYNJ0382048N: UDI/DI 10195327537364 (each) 40195327537365 (case)
Lot #
23JBV598A; 35) Pack Number DYNJ45122C: UDI/DI 10193489496369 (each) 40193489496360 (case)
Lot #
21EME856A; 36) Pack Number DYNJ55648: UDI/DI 10889942581900 (each) 40889942581901 (case)
Lot #
21LBN735A; 37) Pack Number DYNJ04381J: UDI/DI 10888277745155 (each) 40888277745156 (case)
Lot #
23GMB245A; 38) Pack Number DYNJ24300M: UDI/DI 10193489823608 (each) 40193489823609 (case)
Lot #
23FBL428A; 39) Pack Number DYNJ0369758N: UDI/DI 10193489501247 (each) 40193489501248 (case)
Lot #
22GBO541Z; 40) Pack Number DYNJ43038N: UDI/DI 10195327263911 (each) 40195327263912 (case)
Lot #
23EMD464A; 41) Pack Number DYNJ65641: UDI/DI 10193489282986 (each) 40193489282987 (case)
Lot #
21BBF660A; 42) Pack Number DYNJ67442B: UDI/DI 10195327133542 (each) 40195327133543 (case)
Lot #
23DBR515A; 43) Pack Number DYNJ59399I: UDI/DI 10195327442071 (each) 40195327442072 (case)
Lot #
23HMB191A; 44) Pack Number DYNJ0373237M: UDI/DI 10193489369014 (each) 40193489369015 (case)
Lot #
23LBU493Z; 45) Pack Number DYNJ66165: UDI/DI 10193489319729 (each) 40193489319720 (case)
Lot #
20DBP548A; 46) Pack Number DYNJ41134B: UDI/DI 10889942011643 (each) 40889942011644 (case)
Lot #
21BBI489A; 47) Pack Number DYNJ61260A: UDI/DI 10193489857481 (each) 40193489857482 (case)
Lot #
21HMF542A; 48) Pack Number DYNJ60635: UDI/DI 10193489518153 (each) 40193489518154 (case)
Lot #
21IMG997A; 49) Pack Number DYNJ42602C: UDI/DI 10195327019198 (each) 40195327019199 (case)
Lot #
23BBR329A; 50) Pack Number DYNJ32897J: UDI/DI 10193489648102 (each) 40193489648103 (case)
Lot #
20AKB914A; 51) Pack Number DYNJ39912B: UDI/DI 10889942705078 (each) 40889942705079 (case)
Lot #
21GMA579A; 52) Pack Number DYNJ53112B: UDI/DI 10193489650617 (each) 40193489650618 (case)
Lot #
21IMF023A; 53) Pack Number DYNJ51844B: UDI/DI 10889942615773 (each) 40889942615774 (case)
Lot #
21LME446A; 54) Pack Number DYNJ0854874R: UDI/DI 10195327094966 (each) 40195327094967 (case)
Lot #
22CMB704A; 55) Pack Number DYNJ54750G: UDI/DI 10195327021351 (each) 40195327021352 (case)
Lot #
22GBH035A; 56) Pack Number DYNJ22036F: UDI/DI 10889942528899 (each) 40889942528890 (case)
Lot #
20FBH674A; 57) Pack Number DYNJ44015B: UDI/DI 10193489215939 (each) 40193489215930 (case)
Lot #
23EMD927A; 58) Pack Number DYNJ45048C: UDI/DI 10193489808889 (each) 40193489808880 (case)
Lot #
21IMD394A; 59) Pack Number DYNJ0394805N: UDI/DI 10193489245240 (each) 40193489245241 (case)
Lot #
23LME396A; 60) Pack Number DYNJ33544L: UDI/DI 10195327279318 (each) 40195327279319 (case)
Lot #
23LMF755A; 61) Pack Number DYNJ0394730P: UDI/DI 10193489430943 (each) 40193489430944 (case)
Lot #
21LMG091A; 62) Pack Number DYNJ58386A: UDI/DI 10193489397468 (each) 40193489397469 (case)
Lot #
21VBB871A; 63) Pack Number DYNJ80309: UDI/DI 10195327023218 (each) 40195327023219 (case)
Lot #
23LMF645A; 64) Pack Number DYNJ45376G: UDI/DI 10195327209353 (each) 40195327209354 (case)
Lot #
23KMD075A; 65) Pack Number DYNJ48288C: UDI/DI 10888277745599 (each) 40888277745590 (case)
Lot #
21IMH225A; 66) Pack Number DYNJ54979: UDI/DI 10889942519910 (each) 40889942519911 (case)
Lot #
21LBL535Z; 67) Pack Number DYNJ64883C: UDI/DI 10193489369670 (each) 40193489369671 (case)
Lot #
23BBR373A; 68) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case)
Lot #
23GME703A; 69) Pack Number DYNJ43945I: UDI/DI 10193489704242 (each) 40193489704243 (case)
Lot #
23HMC425A; 70) Pack Number DYNJ67426A: UDI/DI 10195327049317 (each) 40195327049318 (case)
Lot #
23HMC554A; 71) Pack Number DYNJ41863C: UDI/DI 10195327463632 (each) 40195327463633 (case)
Lot #
23HBW577A; 72) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case)
Lot #
20EBI994A; 73) Pack Number DYNJ60681A: UDI/DI 10193489780819 (each) 40193489780810 (case)
Lot #
21BBI579A

What the firm is doing

Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583

DistributionShow details

Worldwide distribution - US Nationwide and the country of Canada.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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