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ActiSplint with Sensi-Wrap
Dynarex Corporation · Model 3533 · UDI-DI 00840117349247
0
510(k) clearances
13
Adverse events
1
Recalls
167
Facilities
Description
ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs
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.