Reported May 12, 2021 · Ongoing
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be…
Oto Med 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: Oto Med Inc · 1090 Empire Dr · Lake Havasu City, AZ · 86404-2429
Is this the product you have?
- Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR ***
- Stainless steel filter - Product Usageintended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use
- Lot codes and dates
- UDI Code00850000126046
- Lot Numbers019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200401
- Amount recalled
- 13,335 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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