FDA Device recall Z-0404-2016
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only by Sterilmed, citing sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0404-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-13 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sterilmed |
| Distribution | US |
Product
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Reason
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.
Identifiers
| code_info | All lot numbers with expiration dates 2016-07 or prior. Lot Number 1720009 1757854 1758629 1768646 1774412 17846…All lot numbers with expiration dates 2016-07 or prior. Lot Number 1720009 1757854 1758629 1768646 1774412 1784664 1786626 1795911 1797605 1800714 1801676 1802271 1805472 1807344 1807744 1809011 1809184 1809195 1809910 1810063 1812006 1812312 1812365 1812545 1812561 1812567 1812740 1812883 1813141 1813511 1813959 1814040 1814199 1814219 1814223 1814231 1814651 1814671 1814751 1814989 1815220 1815362 1815371 1815416 1815427 1815591 1815611 1815908 1816182 1816186 1816268 1816269 1816511 1816512 1816513 1816514 1816516 1816558 1816719 1816734 1816737 1816761 1816851 1816853 1816854 1816856 1816858 1816862 1816864 1817011 1817012 1817026 1817043 1817044 1817054 1817056 1817171 1817172 1817181 1817182 1817187 1817194 1817215 1817221 1817229 1817244 1817273 1817275 1817276 1817362 1817368 1817370 1817371 1817377 1817378 1817387 1817388 1817389 1817390 1817391 1817392 1817394 1817396 1817 |
|---|
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-0404-2016%22
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