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Prometheus Omni Splint Rolled
SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · Model PDF105 · UDI-DI 05060483570099
0
510(k) clearances
13
Adverse events
1
Recalls
164
Facilities
Description
The Prometheus Omni Splint™ is intended to be used to aid support and immobilize a patient’s limb(s).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-01 | 3M Company - Health Care Business | Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus. |
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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.