Stryker tourniquet cuffs may detach from the bladder welding connection
Stryker Sustainability Solutions is recalling Color Cuff tourniquet cuffs because the cuff can detach from the bladder at the welding connection, leaving it unable to maintain pressure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a surgical tourniquet that may fail to maintain pressure, a risk of harm with no injuries reported in the source.
Plain-English summary
Stryker Sustainability Solutions is recalling Color Cuff tourniquet cuffs in several sizes and configurations, including the 24-inch yellow and 18-inch red quick connect dual port single bladder versions, REF 5921-024-235 and 5921-018-135, with the full list in the recall notice. The action covers 56,740 cuffs.
The recall is due to the potential for tourniquet cuffs to detach from the bladder at the welding connection, which can result in the cuff not being able to maintain pressure. The FDA classified the action as Class II.
Distribution was across the United States, covering the great majority of states. The cuffs are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF numbers, UDI-DI codes and serial or lot numbers in the recall notice, quarantine it, and follow the instructions issued by Stryker.
The recalled product
- Product
- Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18"…
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 56,740
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 5921-018-135 COLOR CUFF SINGLE PORT
- SINGLE BLADDER 18" (RED)
- SINGLE BLADDER 24" (YELLOW)
Distribution
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