Z-3274-2011

Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40" and 60", set, luer...

Name: Z-3274-2011 Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40" and 60", set, luer...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2011-08-25
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2011-08-25 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40" and 60", set, luer lock. Rx only. Stryker Instruments Div. of Stryker... on 2011-08-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3274-2011
Status: Terminated
Initiated: 2011-08-25
Posted: 2011-09-21
Terminated: 2011-10-12
Recalling firm: Stryker Corp.
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.
Product code: KCY Tourniquet, Pneumatic
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.
Root cause tag: labeling and UDI
FDA 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 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
Product codes and lots: 60" Part number 5920-000-003; lot number 11137012. 40" Part number 5920-000-005; lot number 11138012.

Product code KCY

K952038Class IClean-CuffInstrumed, Inc. / cleared 1995-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)