The Recall Desk
LowFDA (Devices)·Z-2348-2015·Announced 2015-08-12

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.

What this means for you

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 tournique
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.

See all 2 products in this recall →