Flexima Regular Kit Biliary Catheter System Kit, Material... (Boston Scientific Corporation) – there is the potential for holes in t... (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027
Products Sold
GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027
Boston Scientific Corporation is recalling Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage cath due to There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026