Sterilmed Recalls Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling
Sterilmed is recalling 43 reprocessed Zimmer tourniquet cuffs because they are labeled as single hose but are actually dual hose devices.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding device configuration (single vs. dual hose) without reported injuries, fitting the criteria for moderate severity.
Plain-English summary
Sterilmed, Inc. is recalling 43 units of reprocessed Zimmer Tourniquet Cuffs, Part #ZIM60-7075-106, Lot 1846885. The recall was initiated due to a mislabeling error where the packaging identifies the devices as single hose, but the actual devices inside are dual hose.
The affected products were distributed nationwide in California, Kentucky, Michigan, Ohio, Utah, and Wisconsin. Each sales unit contains five individually packaged devices in a Tyvek/poly pouch.
Healthcare facilities and consumers should stop using the affected tourniquet cuffs and contact Sterilmed, Inc. for instructions on return or replacement.
The recalled product
- Product
- Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box.…
- Manufacturer
- STERILMED, INC.
- Hazard
- Affected units
- 43
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 1846885
Distribution
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