CLASS II Device recall · Reported 7 Oct 2015 · FDA Enforcement Report
Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose recalled
Sterilmed is recalling Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), distributed nationwide in the US. The recall was initiated on 24 Aug 2015 and the FDA has classified it as Class II.
Check your package
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-2819-2015
- FDA event ID
- 72035
- Recalling firm
- Sterilmed, Maple Grove, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2015
- FDA classified
- 28 Sep 2015
- Reported
- 7 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 24 Aug 2015 | Recall initiated by company | |
| 28 Sep 2015 | Classified by FDA | +35 days |
| 7 Oct 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.
Product as listed by the FDA
Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
Where it was distributed
US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
Questions about this recall
Why was it recalled?
Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.
Which lots are affected?
Lot 1846885
Where was it sold?
US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
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.
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