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OneCath
COMPACTCATH, INC. · Model 202-1614 · UDI-DI 00852141007246
EZC
Prescription
7
510(k) clearances
10,370
Adverse events (1 deaths)
10
Recalls
26
Facilities
Description
The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-03 | C.R. Bard Inc | Cather packaging may contain the incorrect French size. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2017-12-13 | C.R. Bard, Inc. | Foley Catheter with Incorrect Retainer Cap Print |
| 2012-06-29 | C.R. Bard, Inc., Urological Division | Incomplete seal on sterile packages of product. |
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Get your free API keyRead the docsData 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.