Zimmer Surgical Recalls Tourniquet Cuffs Due to Missing Instructions
Zimmer Surgical Inc. is recalling 61 units of 18-inch disposable tourniquet cuffs because the folded instructions for use pamphlet was missing usage instructions and warnings.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation issue (missing instructions) rather than a physical defect or contamination, and the source text does not report any injuries or illnesses.
Plain-English summary
Zimmer Surgical Inc. is recalling 61 units of 18-inch Dual Port/Single Bladder Disposable Tourniquet Cuffs. The recall is due to a documentation defect where the inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
The affected product is identified by Item 60707000300 and Lot Z000002044. These tourniquets are intended to be used by qualified medical professionals to exert pressure on arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
The units were distributed worldwide, including to 46 US states and the District of Columbia, as well as internationally to Canada. Consumers and medical professionals should check their inventory for this specific lot number and item code. If the product is found, it should be returned to the supplier or the manufacturer for credit or replacement.
The recalled product
- Product
- 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder…
- Manufacturer
- Zimmer Surgical Inc
- Hazard
- Affected units
- 61
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 (2)
- Item 60707000300
- Lot Z000002044
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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