Boston Scientific Corporation recalls vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a p…
- Recall date
- July 18, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3150-2024
- FDA classification
- Class II
- Brand / firm
- Boston Scientific Corporation
- Sold / distributed
- US, Colombia, Philippines, Russia
Why it was recalled
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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