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RecallWatchMedical Device Safety
Class IIOngoingZ-1441-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) ABLATION 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) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ80438; 6) DONOR FREE FLAP PACK-LF, Pack Number DYNJ0426069N; 7) ENT PACK, Pack Number DYNJ50915B; 8) GENERAL LAPAROSCOPY PACK, Pack Number DYNJ63363G; 9) GENERAL LAPAROSCOPY PACK-LF, Pack Number DYNJ0415393J; 10) GENERAL LAPAROSCOPY PLUS, Pack Number DYNJ66729; 11) GERMANTOWN GENERAL LAP CHO, Pack Number DYNJ60998; 12) KOS LAPAROSCOPY PACK-LF, Pack Number DYNJ51663B; 13) LAP CHOLE, Pack Number DYNJ59943C; 14) LAP CHOLE, Pack Number DYNJ904625D; 15) LAP CHOLE, Pack Number DYNJ902780D; 16) LAP CHOLE I-LF, Pack Number DYNJ83414; 17) LAP CHOLE PACK, Pack Number DYNJ51502A; 18) LAP CHOLE PACK, Pack Number DYNJ16657G; 19) LAP CHOLE PACK, Pack Number DYNJ37370B; 20) LAP CHOLE PACK, Pack Number DYNJ26209N; 21) LAP CHOLE PACK, Pack Number DYNJ04581P; 22) LAP CHOLE PACK, Pack Number DYNJ67745A; 23) LAP CHOLE PACK-LF, Pack Number DYNJ09820J; 24) LAP CHOLE TRAY-LF, Pack Number DYNJ48884C; 25) LAPAROSCOPIC, Pack Number DYNJ57709B; 26) LAPAROSCOPIC COLORECTAL PACK, Pack Number DYNJ80172B; 27) LAPAROSCOPIC PACK, Pack Number DYNJ46550F; 28) LAPAROSCOPIC PACK, Pack Number DYNJ63472; 29) LAPAROSCOPY ESC, Pack Number DYNJ902455I; 30) LAPAROSCOPY PACK, Pack Number DYNJ61652; 31) LAPAROSCOPY PACK, Pack Number DYNJHS0235C; 32) LAPAROSCOPY PACK, Pack Number DYNJ21605J; 33) LAPAROTOMY PACK, Pack Number DYNJ52642F; 34) LAPAROTOMY PACK, Pack Number DYNJ59313B; 35) LEX CYSTO-TUR, Pack Number DYNJ902039F; 36) LUKENS MAJOR PACK, Pack Number DYNJ83049; 37) MAIN & ODS CYSTO PACK, Pack Number DYNJ66821A; 38) MAJOR BASIN PACK, Pack Number DYNJ16629D; 39) MAJOR LAPAROTOMY PACK, Pack Number DYNJ67695A; 40) MAJOR SINGLE BASIN W/GOWNS, Pack Number DYNJS3032; 41) MINOR ABDOMINAL, Pack Number DYNJ44675K; 42) MINOR PACK, Pack Number DYNJ46190G; 43) MINOR PACK, Pack Number DYNJ68885A; 44) MINOR PACK, Pack Number DYNJ45578B; 45) MINOR PACK, Pack Number DYNJ43784A; 46) MINOR PACK-LF, Pack Number DYNJ04690Y; 47) MINOR PROCEDURE PACK, Pack Number DYNJQ0629F; 48) MINOR PROCEDURE PACK, Pack Number DYNJ69256; 49) MINOR UROLOGY PACK, Pack Number DYNJ49310F; 50) MLD PACK, Pack Number DYNJ19521P; 51) MP LAP CHOLE, Pack Number DYNJ49947G; 52) NHCH GENERAL PACK, Pack Number DYNJ51573C; 53) NHCH LAPAROSCOPY PACK, Pack Number DYNJ51575B; 54) ONCOLOGY MINOR PACK, Pack Number DYNJ52087J; 55) ONCOLOGY MINOR PACK, Pack Number DYNJ52087J; 56) PED LAPAROTOMY PACK, Pack Number DYNJ55538B; 57) PK, URO-CYSTO, Pack Number DYNJ44022B; 58) RF LAP CHOLEPACK (LCLUI)642-LF, Pack Number DYNJ47704G; 59) ROBOT PROSTATECTOMY PACK, Pack Number DYNJ82688; 60) ROBOTIC PACK, Pack Number DYNJ82436A; 61) ROBOTICS PACK, Pack Number DYNJ83622; 62) RR-LAP NEPHRECTOMY PACK-LF, Pack Number DYNJ0785763L; 63) SC LAPAROSCOPY, Pack Number DYNJ49994I; 64) SCRIPPS HEALTH LAPAROSCOPY PK, Pack Number DYNJ66233A; 65) SMALL PROCEDURE PACK, Pack Number DYNJ55378C; 66) TUR / CYSTO PACK, Pack Number DYNJ69574A; 67) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J; 68) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J; 69) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J

Lot / code information

Lot #
21EME542A; 2) Pack Number DYNJ67756A: UDI/DI 10193489847079 (each) 40193489847070 (case)
Lot #
21LBH976A; 3) Pack Number DYNJ60934B: UDI/DI 10195327080785 (each) 40195327080786 (case)
Lot #
22GBX458A; 4) Pack Number DYNJ61095D: UDI/DI 10195327452674 (each) 40195327452675 (case)
Lot #
23LMF912A; 5) Pack Number DYNJ80438: UDI/DI 10195327038557 (each) 40195327038558 (case)
Lot #
22GBI566A; 6) Pack Number DYNJ0426069N: UDI/DI 10195327371319 (each) 40195327371310 (case)
Lot #
23HMC076A; 7) Pack Number DYNJ50915B: UDI/DI 10193489213478 (each) 40193489213479 (case)
Lot #
23EMC403A; 8) Pack Number DYNJ63363G: UDI/DI 10195327273330 (each) 40195327273331 (case)
Lot #
23HMC803A; 9) Pack Number DYNJ0415393J: UDI/DI 10193489803273 (each) 40193489803274 (case)
Lot #
21JMH176A; 10) Pack Number DYNJ66729: UDI/DI 10193489374933 (each) 40193489374934 (case)
Lot #
22GBH503A; 11) Pack Number DYNJ60998: UDI/DI 10193489546149 (each) 40193489546140 (case)
Show 59 more code fields
Lot #
21GMD619A; 12) Pack Number DYNJ51663B: UDI/DI 10889942965250 (each) 40889942965251 (case)
Lot #
22CMG200A; 13) Pack Number DYNJ59943C: UDI/DI 10195327042547 (each) 40195327042548 (case)
Lot #
21LBI099A; 14) Pack Number DYNJ904625D: UDI/DI 10193489419863 (each) 40193489419864 (case)
Lot #
22IBD797Z; 15) Pack Number DYNJ902780D: UDI/DI 10193489221329 (each) 40193489221320 (case)
Lot #
23GBO958Z; 16) Pack Number DYNJ83414: UDI/DI 10195327264949 (each) 40195327264940 (case)
Lot #
23FMD507A; 17) Pack Number DYNJ51502A: UDI/DI 10193489686326 (each) 40193489686327 (case)
Lot #
21BBD357A; 18) Pack Number DYNJ16657G: UDI/DI 10193489362619 (each) 40193489362610 (case)
Lot #
21GMD931A; 19) Pack Number DYNJ37370B: UDI/DI 10889942223633 (each) 40889942223634 (case)
Lot #
21IMF238A; 20) Pack Number DYNJ26209N: UDI/DI 10193489483161 (each) 40193489483162 (case)
Lot #
22CMF620A; 21) Pack Number DYNJ04581P: UDI/DI 10193489555479 (each) 40193489555470 (case)
Lot #
23DMB984A; 22) Pack Number DYNJ67745A: UDI/DI 10195327409401 (each) 40195327409402 (case)
Lot #
24ABA563Z; 23) Pack Number DYNJ09820J: UDI/DI 10888277840928 (each) 40888277840929 (case)
Lot #
21BBG608A; 24) Pack Number DYNJ48884C: UDI/DI 10193489476651 (each) 40193489476652 (case)
Lot #
21LMF921A; 25) Pack Number DYNJ57709B: UDI/DI 10193489424065 (each) 40193489424066 (case)
Lot #
23JBR204A; 26) Pack Number DYNJ80172B: UDI/DI 10195327359188 (each) 40195327359189 (case)
Lot #
23FBM928A; 27) Pack Number DYNJ46550F: UDI/DI 10193489338812 (each) 40193489338813 (case)
Lot #
20LKB332A; 28) Pack Number DYNJ63472: UDI/DI 10193489745597 (each) 40193489745598 (case)
Lot #
23EBD908A; 29) Pack Number DYNJ902455I: UDI/DI 10193489309584 (each) 40193489309585 (case)
Lot #
20HBJ365Z; 30) Pack Number DYNJ61652: UDI/DI 10193489586855 (each) 40193489586856 (case)
Lot #
20JKA923A; 31) Pack Number DYNJHS0235C: UDI/DI 10889942635245 (each) 40889942635246 (case)
Lot #
21JMA297A; 32) Pack Number DYNJ21605J: UDI/DI 10195327108700 (each) 40195327108701 (case)
Lot #
22BMG822Z; 33) Pack Number DYNJ52642F: UDI/DI 10195327441302 (each) 40195327441303 (case)
Lot #
23HMB247A; 34) Pack Number DYNJ59313B: UDI/DI 10195327248338 (each) 40195327248339 (case)
Lot #
23LME174A; 35) Pack Number DYNJ902039F: UDI/DI 10195327390631 (each) 40195327390632 (case)
Lot #
23GBO615Z; 36) Pack Number DYNJ83049: UDI/DI 10195327234300 (each) 40195327234301 (case)
Lot #
23AMI041A; 37) Pack Number DYNJ66821A: UDI/DI 10193489974928 (each) 40193489974929 (case)
Lot #
23IBJ792A; 38) Pack Number DYNJ16629D: UDI/DI 10889942870585 (each) 40889942870586 (case)
Lot #
20HKB315A; 39) Pack Number DYNJ67695A: UDI/DI 10195327512200 (each) 40195327512201 (case)
Lot #
23LMG985A; 40) Pack Number DYNJS3032: UDI/DI 10884389408407 (each) 40884389408408 (case)
Lot #
23BBO868Z; 41) Pack Number DYNJ44675K: UDI/DI 10195327127480 (each) 40195327127481 (case)
Lot #
23BDA249A; 42) Pack Number DYNJ46190G: UDI/DI 10195327213855 (each) 40195327213856 (case)
Lot #
23EMD906A; 43) Pack Number DYNJ68885A: UDI/DI 10195327187453 (each) 40195327187454 (case)
Lot #
23FBO338A; 44) Pack Number DYNJ45578B: UDI/DI 10195327059187 (each) 40195327059188 (case)
Lot #
23GBD205A; 45) Pack Number DYNJ43784A: UDI/DI 10889942903047 (each) 40889942903048 (case)
Lot #
23HME180A; 46) Pack Number DYNJ04690Y: UDI/DI 10195327381752 (each) 40195327381753 (case)
Lot #
23DME413A; 47) Pack Number DYNJQ0629F: UDI/DI 10889942565559 (each) 40889942565550 (case)
Lot #
21FBP134A; 48) Pack Number DYNJ69256: UDI/DI 10193489918151 (each) 40193489918152 (case)
Lot #
21JMI098A; 49) Pack Number DYNJ49310F: UDI/DI 10195327546373 (each) 40195327546374 (case)
Lot #
23LMF829A; 50) Pack Number DYNJ19521P: UDI/DI 10193489941197 (each) 40193489941198 (case)
Lot #
21IMD905A; 51) Pack Number DYNJ49947G: UDI/DI 10193489474152 (each) 40193489474153 (case)
Lot #
21GMD742A; 52) Pack Number DYNJ51573C: UDI/DI 10195327561222 (each) 40195327561223 (case)
Lot #
23LMG544A; 53) Pack Number DYNJ51575B: UDI/DI 10195327132248 (each) 40195327132249 (case)
Lot #
22JMB950A; 54) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case)
Lot #
23LMD323A; 55) Pack Number DYNJ52087J: UDI/DI 10195327467104 (each) 40195327467105 (case)
Lot #
23LMD611A; 56) Pack Number DYNJ55538B: UDI/DI 10193489574630 (each) 40193489574631 (case)
Lot #
21BBG139A; 57) Pack Number DYNJ44022B: UDI/DI 10193489429329 (each) 40193489429320 (case)
Lot #
22DBR220Z; 58) Pack Number DYNJ47704G: UDI/DI 10195327380724 (each) 40195327380725 (case)
Lot #
23FMF488A; 59) Pack Number DYNJ82688: UDI/DI 10195327202903 (each) 40195327202904 (case)
Lot #
23LMG154A; 60) Pack Number DYNJ82436A: UDI/DI 10195327362607 (each) 40195327362608 (case)
Lot #
23EMD052A; 61) Pack Number DYNJ83622: UDI/DI 10195327285753 (each) 40195327285754 (case)
Lot #
23FBN812A; 62) Pack Number DYNJ0785763L: UDI/DI 10193489351095 (each) 40193489351096 (case)
Lot #
21LMF965A; 63) Pack Number DYNJ49994I: UDI/DI 10195327065775 (each) 40195327065776 (case)
Lot #
21LMF123A; 64) Pack Number DYNJ66233A: UDI/DI 10195327176600 (each) 40195327176601 (case)
Lot #
23LME717A; 65) Pack Number DYNJ55378C: UDI/DI 10193489443776 (each) 40193489443777 (case)
Lot #
22GBJ071A; 66) Pack Number DYNJ69574A: UDI/DI 10195327242473 (each) 40195327242474 (case)
Lot #
22JBI116Z; 67) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case)
Lot #
22CMA803A; 68) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case)
Lot #
22KMA579A; 69) DYNJ0365463J: UDI/DI 10193489783872 (each) 40193489783873 (case)
Lot #
22KMA581A

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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