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Terminated

Stryker PainPump2 400 mL Painpump with Luer Lock Tubing Set, REF 540-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.

FDA Recall Z-0097-2011 · Posted 2010-10-20

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-08-16
Date Terminated2011-04-21
Product Quantity11,976 all products

Reason for Recall

The instructions for use (IFU) has been revised for health care professionals. The indication for use has been changed to remove site specific pain management. The firm has revised the warning to not use the pump around joint spaces. A warning has been added regarding the use of the pump with anticoagulants in epidural applications. A special reminder to users to always evaluate the potential

Firm Action

Stryker Instruments sent Urgent Medical Device Recall Notification letters dated 8/16/2010 to healthcare professionals. The recall letters outlined the changes for the instructions for the use of these products. The letters informed the healthcare professional to review the new IFU, to distribute the new IFU to all healthcare professionals that use the device, and to complete and return the business reply form. The letters included a complete IFU that was to be used with any remaining stock of devices. Customers should dispose of the old version of the IFU. There is no product being returned for this recall.

Root Cause

Other

Distribution Pattern

US, Canada and Australia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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