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Accuryn Monitor High Mount
POTRERO MEDICAL, INC. · Model FGN-06-102112 · UDI-DI 00850019755244
10
510(k) clearances
9,552
Adverse events (12 deaths)
85
Recalls
116
Facilities
Description
The Accuryn Monitor High Mount is used to hold Accuryn Monitor near the patient’s bed during stationary use or transport. The Monitor High Mount can also be placed on top of the Floor Stand to raise the drainage bag up to drain the bag more easily. This monitor mount consists of one molded piece.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-25 | C.R. Bard Inc | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| 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. |
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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.