—#94281

Product

Stryker PainPump2 250 mL Painpump with Luer Lock Tubing Set, REF 525-350, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042405, K043466
Affected lot / code info: '09160012, '09163012, '09176012, '09197012, '09198012, '09203012, '09211012, '09213022, '09217012, '09222012, '09230012, '09234012, '09241012, '09246012, '09258012, '09262012, '09283012, '09289012, '09290012, '09292022, '10012012, '10013012, '10014012, '10015012, '10018022, '10019012, '10021012, '10028012, '10029012, '10032022, '10033012, and '10039022.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Kalamazoo, Michigan 49001

Distribution

Distribution pattern: US, Canada and Australia.

Timeline

Recall initiated: 2010-08-16
Posted by FDA: 2010-10-20
Terminated: 2011-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.