Reported Nov 9, 2016 · Terminated

Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a…

Stryker Sustainability Solutions

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327

Is this the product you have?

Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

Lot codes and dates: Model Lot Lot Created Expiration
3,401 of 3,401 codes
5921-018-135
2990595
5/5/2014
May-16
5921-018-235
2989898
5/5/2014
May-16
5921-018-235
2992868
5/5/2014
May-16
5921-024-235
2992501
5/5/2014
May-16
5921-030-135
2990147
5/5/2014
May-16
5921-030-135
2991575
5/5/2014
May-16
5921-030-235
2993033
5/5/2014
May-16
5921-034-135
2990152
5/5/2014
May-16
5921-034-135
2992555
5/5/2014
May-16
5921-034-235
2989674
5/5/2014
May-16
5921-034-235
2990240
5/5/2014
May-16
5921-034-235
2991095
5/5/2014
May-16
5921-034-235
2991413
5/5/2014
May-16
5921-034-235
2993046
5/5/2014
May-16
5921-034-235
2993509
5/5/2014
May-16
Amount recalled: 1,695,760

Where it was sold

Nationwide

Why it was recalled

Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.

This product could cause temporary or reversible health problems — stop using it.

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