—#103747

Product

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 to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box.

FDA product code: KCY — Tourniquet, Pneumatic
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K952038
Affected lot / code info: 60" Part number 5920-000-003; lot number 11137012. 40" Part number 5920-000-005; lot number 11138012.

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Worldwide Distribution: Nationwide Distribution including the states of HAWAII, NORTH DAKOTA, NEBRASKA, PENNSYLVANIA, and IOWA, and the country of FRANCE

Timeline

Recall initiated: 2011-08-25
Posted by FDA: 2011-09-21
Terminated: 2011-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.