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 Recall Z-3274-2011 · Posted 2011-09-21
Advertisement
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeKCY
Date Initiated2011-08-25
Date Terminated2011-10-12
Product Quantity5920-000-003 (30 bx) and 5920-000-005 (30 bx)
Reason for Recall
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.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution: Nationwide Distribution including the states of HAWAII, NORTH DAKOTA, NEBRASKA, PENNSYLVANIA, and IOWA, and the country of FRANCE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement