Reprocessed Stryker Color Cuff and Color Cuff II Adult recall: Labeling Error
Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235…
Why was Reprocessed Stryker Color Cuff and Color Cuff II Adult recalled?
Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235…
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 450 devices
- Distribution
- Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.
- Recall date
- January 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)