REF: 5921-018-135 recall: Labeling Error
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Why was REF: 5921-018-135 recalled?
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
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?
Lot # 12983349
- Product
- REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 40 units
- Distribution
- US: KS OK TX OUS: None
- Recall date
- March 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)