CLASS II Device recall · Reported 12 Aug 2015 · FDA Enforcement Report

Dual Port/Single Bladder Disposable Tourniquet Cuff recalled

Zimmer Surgical is recalling Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets, distributed in 45 states. The recall was initiated on 24 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 60707000300, Lot Z000002044

Quantity recalled61 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2348-2015
FDA event ID: 71575
Recalling firm: Zimmer Surgical, Dover, OH
Classification: Class II
Status: Terminated
Recall initiated: 24 Jun 2015
FDA classified: 6 Aug 2015
Reported: 12 Aug 2015
Type: N/A
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

24 Jun 2015	Recall initiated by company
6 Aug 2015	Classified by FDA	+43 days
12 Aug 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

Product as listed by the FDA

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 tourniquet cuffs are generally used for operations lasting less than 90 minutes.

Where it was distributed

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.

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Questions about this recall

Why was it recalled?

The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

Which lots are affected?

Item 60707000300, Lot Z000002044

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 71575

This product is part of a recall event; the main page for the event is Dual Port/Single Bladder Disposable Tourniquet Cuff recalled.

Reported	Class	Recall	Company	Reason	Where
12 Aug 2015	CLASS II	Dual Port/Single Bladder Disposable Tourniquet Cuff recalled	Zimmer Surgical	Other	45 states

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