Home › MCKESSON MEDICAL-SURGICAL INC. › McKesson
McKesson
MCKESSON MEDICAL-SURGICAL INC. · Model 16-SFOL516 · UDI-DI 10612479245331
EZL
Prescription
10
510(k) clearances
9,331
Adverse events (12 deaths)
84
Recalls
115
Facilities
Description
CATHETER, FOLEY STRAIGHT TIP SILICONE 16" 16FR 5-10CC
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-23 | C.R. Bard Inc | Due to stain present on the surface of affected foley catheters. |
| 2025-06-18 | C.R. Bard Inc | Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfuncti |
| 2024-12-02 | Coloplast Manufacturing US, LLC | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. |
| 2024-12-02 | Coloplast Manufacturing US, LLC | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2023-11-06 | Nurse Assist, LLC | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in |
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.