Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 6) ARTHROSCOPY TRAY, Pack Number DYNJ46435A; 7) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50120D
This recall is currently active, issued March 25, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- February 11, 2025
- Posted
- March 25, 2025
- Recall Number
- Z-1452-2025
- Quantity
- 186 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Info
1) Pack Number DYNJHS0101I: UDI/DI 10888277046412 (each) 40888277046413 (case), Lot Number 21LBA780A; 2) Pack Number DYNJ0390808F: UDI/DI 10889942244591 (each) 40889942244592 (case), Lot Number 21JMG164A; 3) Pack Number DYNJ23150J: UDI/DI 10888277742239 (each) 40888277742230 (case), Lot Number 21LMF991A; 4) Pack Number DYNJ21233O: UDI/DI 10889942543878 (each) 40889942543879 (case), Lot Number 22GBQ106M; 5) Pack Number DYNJ21233O: UDI/DI 10889942543878 (each) 40889942543879 (case), Lot Number 22JBA123Z; 6) Pack Number DYNJ46435A: UDI/DI 10889942670901 (each) 40889942670902 (case), Lot Number 23LMG014A; 7) Pack Number DYNJ50120D: UDI/DI 10195327195656 (each) 40195327195657 (case), Lot Number 22JBG571Z
Root Cause
Under Investigation by firm
Action Taken
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