Sump Catheter System Recalled for Potential Sterile Barrier Defect
Boston Scientific is recalling the vanSonnenberg Sump Catheter System Kit because the sterile barrier pouch may have holes that could compromise device sterility. The recall affects 4 units distributed in the US, Colombia, Philippines, and Russia.
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 recall involves a risk-of-harm medical device where sterile barrier failure could lead to device contamination. However, no illnesses, injuries, or deaths have been reported, and the FDA classified this as Class II rather than Class I, meeting the criterion for High severity but not Severe.
Plain-English summary
Boston Scientific Corporation is recalling the vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit (Material Number REF M001273090, Lot 33512377, expiration 02/26/2027). This device is designed for percutaneous placement as a drain for intra-abdominal fluid collections.
The recall is due to the potential for holes in the clear sterile barrier of the device pouch, which may impact the device's sterility. A compromised sterile barrier could allow the device to become contaminated before use.
The recalled lot was distributed to the United States, Colombia, Philippines, and Russia. The recall involves 4 units of the affected product.
Patients and healthcare providers who have received this product should contact Boston Scientific Corporation for instructions regarding the recalled device and any necessary follow-up.
The recalled product
- Product
- vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
- 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 0871472913774
- Lot # 33512377
- exp. 02/26/2027
Distribution
Distribution scope not specified by the agency.
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