—#209692

Product

Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail

FDA product code: FFA — Tube, Drainage, Suprapubic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K211934
Affected lot / code info: GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027

Why it was recalled

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Root cause (FDA determination)

Packaging process control

Action the firm took

Boston Scientific issued am Urgent Medical Device Removal notice to it consignees on 07/18/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the return of the devices. Consignees were directed to post the notice in a visible location near the affected products to ensure visibility and to share the notice with all those to whom the device was transferred. Distributors were direct to notify their customers.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: US, Colombia, Philippines, Russia

Timeline

Recall initiated: 2024-07-18
Posted by FDA: 2024-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209692. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.