FDA Recall Open, Classified

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

Recall: Z-1464-2025 · Initiated February 11, 2025

Recall

Recall Number: Z-1464-2025
Event Number: 96373
Firm: MEDLINE INDUSTRIES, LP Northfield
FEI Number: 1417592
Product Code: OJG
Status: Open, Classified
Root Cause: Under Investigation by firm
Initiated: February 11, 2025
Posted: March 26, 2025
Address: 3 Lakes Dr, Northfield, IL, 60093-2753

Description

Reason

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.

Action

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.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Quantity

422