Reported Jan 20, 2016 · Terminated
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135,…
Stryker Sustainability Solutions
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 Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
- Reprocessed Stryker Color Cuff and Color Cuff
- II Adult Tourniquet Cuffs Model Numbers5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities
- Lot codes and dates
- Model #5921-218-135 Lot #3490521 Model #5921-034-235 Lot #3531111 Model #5921-034-135 Lot #3733336, 4002152 Model #5921-044-135 Lot #3759409 Model #5921-024-236 Lot #3822485
- Amount recalled
- 450 devices
Where it was sold
Why it was recalled
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
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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