Reported Sep 8, 2021 · Terminated
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Aspen Surgical Products, 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: Aspen Surgical Products, Inc. · 6945 Southbelt Dr SE · Caledonia, MI · 49316-7664
Is this the product you have?
Norton Arm KitProduct Code 711400(previous product code 031001)Sample Kit S711400
- Lot codes and dates
All lots manufactured between July 92019 to July 92021
- Amount recalled
- 124
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
- Nationwide
Why it was recalled
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
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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