Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40" and 60", set, luer lock. Rx only
FDA device recall Z-3274-2011 · posted 2011-09-21 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KCY
- Quantity affected
- 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
- Date initiated
- 2011-08-25
- Date posted
- 2011-09-21
- Date terminated
- 2011-10-12
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLEAN-CUFF (K952038) | Instrumed, Inc. | 1995-07-11 |