Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
This recall is currently active, issued March 18, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- February 11, 2025
- Posted
- March 18, 2025
- Recall Number
- Z-1394-2025
- Quantity
- 880 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 - US Nationwide and the country of Canada.
Lot / Code Info
1) 10193489244441 (each) 40195327273133 (case), Lot Number 40193489244442
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 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 94581