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PureWick

C. R. Bard, Inc. · Model PWMX30 · UDI-DI 00801741226465

NZU
1
510(k) clearances
3,993
Adverse events (12 deaths)
1
Recalls
44
Facilities

Description

PureWick Male External Catheter, Home Care

Recalls

DateFirmReason
2023-10-23Sage Products IncA small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.