Boston Scientific VTC Nephrostomy Catheter Kit Recalled for Sterile Barrier Defect
Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.
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 an FDA Class II recall with no reported illnesses or injuries and a theoretical hazard (potential sterile barrier compromise). Per the rubric, recalls with no reported harm and theoretical risk are at most Score 3. The defect poses a risk-of-harm through compromised device sterility, justifying the High classification.
Plain-English summary
Boston Scientific Corporation is recalling the VTC Regular Kit Nephrostomy Catheter System Kit (Material Number REF M001245300) used for external drainage of the urinary tract.
The device pouches may contain holes in the clear sterile barrier. These holes could compromise the sterility of the catheter before clinical use.
The recalled devices were distributed in the United States, Colombia, Philippines, and Russia. The affected lot is 33751204 with an expiration date of 04/03/2027, affecting 5 units.
Healthcare providers and patients should discontinue use of affected units. Contact Boston Scientific for instructions regarding replacement or return of the product.
The recalled product
- Product
- VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- sterile-barrier-defect
- contamination-risk
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 0871472904856
- Lot # 33751204
- exp. 04/03/2027
Distribution
Distribution scope not specified by the agency.
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