Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Num

FDA device recall Z-3054-2024 · posted 2024-09-06 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

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.

Action taken

Medline Industries LP issued a recall notice to its consignees on 04/08/2024 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 these 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. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OII

Distribution

Worldwide distribution.

Date initiated

2024-04-08

Date posted

2024-09-06

Location

Northfield, IL