Zimmer Surgical Recalls Tourniquet Cuffs with Missing Instructions
Zimmer Surgical Inc. is recalling 330 units of 30-inch tourniquet cuffs because the instructions for use were missing usage instructions and warnings.
What this means for you
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 the hazard involves missing safety instructions (documentation issue) without reported injuries, fitting the Moderate criteria for minor labeling/documentation errors.
Plain-English summary
Zimmer Surgical Inc. is recalling 330 units of 30-inch Dual Port/Single Bladder Disposable Tourniquet Cuffs with PLC. The recall involves Item 60707010500, specifically Lot Z000002535 and Lot Z000002541. These medical devices 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.
The recall was initiated because the inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. The affected units were distributed worldwide, including in the United States and Canada.
Healthcare facilities and consumers should stop using the affected tourniquet cuffs and contact Zimmer Surgical Inc. for further instructions or a replacement.
The recalled product
- Product
- 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, 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
- 330
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 (3)
- Item 60707010500
- Lot Z000002535 & Item 60707010500
- Lot Z000002541.
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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