Reported Sep 6, 2023 · Ongoing
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting,…
Stryker Corporation
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: Stryker Corporation · 1941 Stryker Way · Portage, MI · 49002-9711
Is this the product you have?
- SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used
- during surgical procedures Product Code0694-002-090
- Lot codes and dates
- GTIN 07613327543094 Software Version2.1.8 & 2.20
- Amount recalled
- 57 units
Where it was sold
- Nationwide
Why it was recalled
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
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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