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Open, Classified

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

FDA Recall Z-3148-2024 · Posted 2024-09-13

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeFFA
Date Initiated2024-07-18
Product Quantity32 units

Reason for Recall

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

Firm Action

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.

Root Cause

Packaging process control

Distribution Pattern

US, Colombia, Philippines, Russia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenbergBoston Scientific Corporation · 2022-11-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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