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 tourniquet cuffs are generally used for operations lasting less than 90 minutes.
Reported: August 12, 2015 Initiated: June 24, 2015 #Z-2349-2015
Product Description
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 tourniquet cuffs are generally used for operations lasting less than 90 minutes.
Reason for Recall
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Details
- Recalling Firm
- Zimmer Surgical Inc
- Units Affected
- 330 units
- Distribution
- Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada.
- Location
- Dover, OH
Frequently Asked Questions
What product was recalled? ▼
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 tourniquet cuffs are generally used for operations lasting less than 90 minutes.. Recalled by Zimmer Surgical Inc. Units affected: 330 units.
Why was this product recalled? ▼
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 12, 2015. Severity: Moderate. Recall number: Z-2349-2015.
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