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McKesson
MCKESSON MEDICAL-SURGICAL INC. · Model 16-M1612 · UDI-DI 10612479213682
10
510(k) clearances
2,601
Adverse events (4 deaths)
18
Recalls
79
Facilities
Description
Catheter Urethral Male 16" 12FR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-14 | Hollister Ulc | Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary |
| 2025-11-29 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | Labeling error, Incorrect expiration date |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2018-03-15 | Teleflex Medical Europe Ltd | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause All |
| 2011-04-21 | Coloplast Manufacturing US, LLC | Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the ov |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis |
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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.