Zimmer Tourniquet Cuff Recalled Due to Incorrect Port Configuration Labeling
Stryker is recalling 90 units of Zimmer Tourniquet Cuff 30" because packaging labels them as dual port single bladder, but they actually contain a single port single bladder configuration.
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: This FDA Class II recall involves a labeling discrepancy where packaging incorrectly describes the actual product configuration. While no illnesses or injuries have been reported, the mislabeling creates a genuine risk of operational confusion or misuse, meeting the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Stryker Sustainability Solutions is recalling 90 units of Zimmer Tourniquet Cuff 30" (Blue), reference number 60-7070-005, due to a packaging labeling error.
The affected tourniquet cuffs are labeled on the packaging as dual port single bladder devices, but the cuffs actually contain a single port single bladder configuration. This mislabeling could cause confusion if healthcare providers or users rely on the packaging label to determine the device's port capability.
The recalled units have lot number 0000564862 (UDI: 00885825015411) and were distributed nationwide in California, Colorado, Illinois, Michigan, Oregon, and Wisconsin.
Healthcare providers and users who have received these tourniquet cuffs should verify the actual port configuration of the device rather than relying on the packaging label. Contact your supplier or Stryker if you believe you have received an affected unit.
The recalled product
- Product
- REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 90
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 (1)
- Lot: 0000564862/ UDI: 00885825015411
Distribution
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