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Custom Medical Specialties, Inc.
CUSTOM ASSEMBLIES, INC. · Model CMS-954P-6 · UDI-DI 00815849020344
10
510(k) clearances
223
Adverse events (1 deaths)
74
Recalls
152
Facilities
Description
Polyvinyl Urological Drainage Bag for GE/OEC Systems w/ 6mm Plug - Non-Sterile
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-13 | Innovative Orthopedic Technologies, LLC | Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
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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.