Recall Z-3274-2011 ยท KCY Tourniquet, Pneumatic
Stryker Instruments Div. of Stryker Corporation
Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40" and 60", set, luer lock. Rx only. Stryker Instruments Div. of Stryker Corporation. Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used
| Date | Sep 21, 2011 (initiated Aug 25, 2011) |
| Status | Terminated |
| Reason | Three complaints have been reported indicating that the product inside the package did not match the label description. The units had quick connectors instead of luer lock connectors as stated in the label description. |
| Root cause | Mixed-up of materials/components |
| Action | Stryker Instruments sent out "Urgent Medical Device Recall" notices dated August 22, 2011 to all affected customers. The letter included the name of the recalled product, lot numbers, and the reason for the recall. Customers were instructed to send back any product to Stryker that is within the affected lots. The letter further stated Stryker will quarantine the product and replace any product that is returned. For information on this recall contact Stryker Instruments at (269) 389-4534. |
| Quantity | 5920-000-003 (30 bx) and 5920-000-005 (30 bx) |
| Distribution | Worldwide Distribution: Nationwide Distribution including the states of HAWAII, NORTH DAKOTA, NEBRASKA, PENNSYLVANIA, and IOWA, and the country of FRANCE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952038 | CLEAN-CUFF Instrumed, Inc., Jul 11, 1995 |