FDA Device recall Z-2348-2015
18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc
- FDA Device
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc by Zimmer Surgical, citing the inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2348-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-24 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer Surgical |
| Distribution | 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 |
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 tourniquet cuffs are generally used for operations lasting less than 90 minutes.
Reason
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Identifiers
| code_info | Item 60707000300, Lot Z000002044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2348-2015%22
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