Stryker Recalls 90 Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling
Stryker Sustainability Solutions is recalling 90 reprocessed Zimmer tourniquet cuffs because they are potentially mislabeled. The mislabeling could lead to device misuse or inadequate limb compression during surgery.
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 involves a high-risk medical device where mislabeling poses a risk of harm (device misuse or inadequate compression) during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Sustainability Solutions is recalling 90 units of the Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder (Item Number: 60-7070-105, UDI: 00885825013868). These are reprocessed tourniquet cuffs indicated for use in patients requiring surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.
The recall was initiated because the devices are potentially mislabeled. If used, this mislabeling may lead to device misuse during the procedure or inadequate limb compression force. The affected units are identified by Lot Number 10237165.
The affected products were distributed nationwide in the United States, including the states of South Carolina, Texas, Utah, New York, and Arkansas. Healthcare facilities and consumers should stop using these specific devices and contact Stryker Sustainability Solutions for further instructions.
The recalled product
- Product
- Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected…
- Manufacturer
- Stryker Sustainability Solutions
- 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 Number 10237165
Distribution
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