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Personal Catheter™ Intermittent Catheter

C. R. Bard, Inc. · Model 63912 · UDI-DI 00801741069369

MJC Prescription
1
510(k) clearances
16,326
Adverse events (1 deaths)
22
Recalls
9
Facilities

Description

Personal Catheter™ Intermittent Catheter Antibacterial Coated Silicone, Male

Recalls

DateFirmReason
2025-07-17C.R. Bard IncFoley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone
2025-07-17C.R. Bard IncFoley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone
2025-07-17C.R. Bard IncFoley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone
2024-05-09C.R. Bard IncSome of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.
2021-08-05C.R. Bard IncThere is potential for packaging defects that may impact the sterile barrier.

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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.