Stryker Recalls Reprocessed Pressure Tourniquet Cuffs Due to Leak Detection Issues
Stryker Sustainability Solutions is recalling 1,695,760 reprocessed pressure tourniquet cuffs because the process for detecting leaks is flawed. Leaking cuffs may cause excessive blood loss or systemic leakage of local anesthetic.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (excessive blood loss or anesthetic leakage) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Stryker Sustainability Solutions is recalling 1,695,760 units of reprocessed Pressure Tourniquet Cuffs (PTC) distributed nationwide in the United States. The recall is due to an issue with the process used to detect leaking PTC devices.
Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, they apply pressure to arterial blood flow to create a bloodless surgical field. The affected lots were created between May 5, 2014, and May 20, 2014, with expiration dates in May or June 2016.
Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention. Additionally, systemic leakage of local anesthetic during a Bier Block procedure may require medical intervention. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood…
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 1,695,760
Distribution
Distributed nationwide across the United States.
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