Boston Scientific Corporation recalls Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of t…
- Recall date
- July 18, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3149-2024
- 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
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
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