—#208737

Product

Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799

FDA product code: EYN — Tray, Irrigation, Sterile
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: DYNJ42742D , Lot Number 19ABF928 ; DYNJ42742D , Lot Number 19BBC938 ; DYNJ42742D , Lot Number 19PBB060 ; DYNJ42742D , Lot Number 19GBO530 ; DYNJ42742D , Lot Number 19HBH965 ; DYNJ42742D , Lot Number 19HBJ692 ; DYNJ42799, Lot Number 21GBH529 ; DYNJ42799, Lot Number 19CBO493 ; DYNJ42799, Lot Number 19EBF614 ; DYNJ42799, Lot Number 19FBD772 ; DYNJ42799, Lot Number 19GBE887 ; DYNJ42799, Lot Number 19HBI404 ; DYNJ42799, Lot Number 19IBT472 ; DYNJ42799, Lot Number 20ABD578 ; DYNJ42799, Lot Number 20CBF124 ; DYNJ42799, Lot Number 20DBC424 ; DYNJ42799, Lot Number 20EBT962 ; DYNJ42799, Lot Number 20JBF487 ; DYNJ42799, Lot Number 20JBZ120 ; DYNJ42799, Lot Number 21ABV059 ; DYNJ42799, Lot Number 21BBM615 ; DYNJ42799, Lot Number 21EBP168 ; DYNJ42799, Lot Number 21EBP171

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-04-08
Posted by FDA: 2024-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208737. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.