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RecallWatchMedical Device Safety
Class IIOngoingZ-1446-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) DELIVERY 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) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LABOR AND DELIVERY TRAY-LF, Pack Number DYNJ23054J; 7) OB DELIVERY-LF, Pack Number DYNJ40096F; 8) VAG DELIVERY PACK, Pack Number DYNJ83056; 9) VAGINAL DELIVERY, Pack Number DYNJ27939D; 10) VAGINAL DELIVERY PACK, Pack Number DYNJ25843C; 11) VAGINAL DELIVERY PACK, Pack Number DYNJ43395; 12) VAGINAL DELIVERY PACK-LF, Pack Number DYNJ0594115L

Lot / code information

Lot #
23IMF426A; 2) Pack Number DYNJ0968863M: UDI/DI 10889942323081 (each) 40889942323082 (case)
Lot #
21JMG530A; 3) Pack Number DYNJ0373290N: UDI/DI 10193489967371 (each) 40193489967372 (case)
Lot #
21IMH700A; 4) Pack Number DYNJ51998A: UDI/DI 10193489923506 (each) 40193489923507 (case)
Lot #
22IBG256Z; 5) Pack Number DYNJ0348455P: UDI/DI 10195327430481 (each) 40195327430482 (case)
Lot #
23HMC532A; 6) Pack Number DYNJ23054J: UDI/DI 10193489215649 (each) 40193489215640 (case)
Lot #
22CMB444A; 7) Pack Number DYNJ40096F: UDI/DI 10193489923094 (each) 40193489923095 (case)
Lot #
23IMF243A; 8) Pack Number DYNJ83056: UDI/DI 10195327234416 (each) 40195327234417 (case)
Lot #
22JMB827A; 9) Pack Number DYNJ27939D: UDI/DI 10195327148232 (each) 40195327148233 (case)
Lot #
22LBE104A; 10) Pack Number DYNJ25843C: UDI/DI 10889942853731 (each) 40889942853732 (case)
Lot #
21EBN038A; 11) Pack Number DYNJ43395: UDI/DI 10888277049444 (each) 40888277049445 (case)
Show 2 more code fields
Lot #
21LMG173A; 12) Pack Number DYNJ0594115L: UDI/DI 10193489382730 (each) 40193489382731 (case)
Lot #
20JKB018A

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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