Flexima Biliary Catheter System Kits recalled for potential sterile barrier failure
Boston Scientific is recalling Flexima Biliary Catheter System Kit (Lot #33512376) due to potential holes in the device pouch's sterile barrier, which could compromise device sterility. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for sterile barrier compromise on an invasive medical device. The rubric criterion 'risk-of-harm products where injury has not yet been reported' applies, as compromised sterility could lead to infection, though no actual illnesses or injuries have been reported.
Plain-English summary
Boston Scientific Corporation is recalling Flexima Regular Kit Biliary Catheter System Kit (Material Number REF M001271650, Lot #33512376, expiration date 02/26/2027) because the clear sterile barrier of the device pouch may have holes that could compromise the device's sterility.
The recalled kits were distributed in the United States, Colombia, Philippines, and Russia. A total of 32 units were affected. The product is a bile drainage catheter with a locking pigtail mechanism.
If you have received this product, do not use it. Contact Boston Scientific for return and replacement instructions.
Compromised sterility in medical devices used for invasive procedures creates a risk of infection or contamination. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN/UDI 0871472932327
- Lot # 33512376
- exp. 02/26/2027
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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