Reported Apr 18, 2018 · Terminated
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO;…
TriMed Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TriMed Inc. · 27533 Avenue Hopkins · Santa Clarita, CA · 91355-3910
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
HXDRIVER-2.0 | Hex Driver AO |
HXDRIVR-2.5 | Hex Driver AO |
HXDRIVR-2.5CL | Hex Driver AO |
DVHX-2.5/130C | Hex Driver AO |
HXDRIVR-3.0 | Hex Driver AO |
HXDRIVER-3.5AO | Hex Driver |
- Lot codes and dates
- Affected lot numbers
922361922362919569195792237922389185892235926569185691857
- Affected lot numbers
- Amount recalled
- 1525 devices
Why it was recalled
Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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