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U.S. Department of Health and Human Services

Class 3 Device Recall Stryker SmartPump Extension Tubing

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  Class 3 Device Recall Stryker SmartPump Extension Tubing see related information
Date Initiated by Firm August 25, 2011
Date Posted September 21, 2011
Recall Status1 Terminated 3 on October 12, 2011
Recall Number Z-3274-2011
Recall Event ID 59791
510(K)Number K952038  
Product Classification Accessories for Pneumatic Tourniquet - Product Code KCY
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.
Code Information 60" Part number 5920-000-003; lot number 11137012. 40" Part number 5920-000-005; lot number 11138012.
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Angela Ragainis
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KCY and Original Applicant = INSTRUMED, INC.