Reported Apr 20, 2016 · Terminated
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product…
Stryker Instruments Div. of 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 Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001
- Product UsageThe SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures
- Lot codes and dates
- Model Number(s)0694-097-000 0694-097-001 Units individually serialized, SN numbers included in recall Letter. Units distributed 11/1/2015-12/17/2015
- Stryker Product Number0694097000 Serial#
258 of 258 codes
152590164315266026931526603463152670835315314000831531400453153140082315259016531526602713152660347315267083931531400093153140046315314008331525901663152660272315266034831526708403153140010315314004731531400843152590167315266027331526603493152670841315314001131531400483153140085315259016831526602743152660350315267084231531400123153140049315314008631525901693152660275315266035131526708443153140013315314005031531400873152590170315266028631526603523152670846315314001431531400513153140088315259017131526602873152660353315267084731531400153153140052315314008931525901723152660288315266035431526708493
- Stryker Product Number0694097001 Serial#
1533400133153340020315323055631526809553153150426315315043031531504293153230560315323055831533400153153340017315323055931527501963152750203315275019731527502013153340014315268095131526809523152680953315268095431527501943152750198315275020231531504273153150428315275019531532305573
- Amount recalled
- 286
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
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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