vanSonnenberg Sump Locking Pigtail Regular Kit Sump recall: Sterility Concern
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for…
Why was vanSonnenberg Sump Locking Pigtail Regular Kit Sump recalled?
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN/UDI 0871472913774, Lot # 33512377, exp. 02/26/2027
- Product
- vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 4 units
- Distribution
- US, Colombia, Philippines, Russia
- Recall date
- September 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)