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RecallWatchMedical Device Safety
Class IIOngoingZ-1464-2025

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF

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) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q; 6) SNI NEURO, Pack Number DYNJ45379D; 7) VP SHUNT PACK, Pack Number DYNJ55558C

Lot / code information

Lot #
20BDB113A; 2) Pack Number DYNJ21519W: UDI/DI (each) 40889942255611 (case)
Lot #
20BDB225A; 3) Pack Number DYNJ83941: UDI/DI (each) 40888277736574 (case)
Lot #
22JBA879Z; 4) Pack Number DYNJ55678: UDI/DI (each) 40193489468688 (case)
Lot #
22JBC551Z; 5) Pack Number DYNJ04851Q: UDI/DI (each) 40889942402176 (case)
Lot #
22JBC798Z; 6) Pack Number DYNJ45379D: UDI/DI (each) 40195327048748 (case)
Lot #
23FME560A; 7) Pack Number DYNJ55558C: UDI/DI (each) 40195327408214 (case)
Lot #
23LMG468A

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.

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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