FDA Device

Stryker 100 mL AutoFuser PainPump, single site continuous, 1.0 mL/hr, 1 x 2.5" ExFen catheter, sterile, REF 0531-100-025. Infusion pump for pain medication.

Hazard

Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.

What You Should Do

Remedy

Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card.

Products

Stryker 100 mL AutoFuser PainPump, single site continuous, 1.0 mL/hr, 1 x 2.5" ExFen catheter, sterile, REF 0531-100-025. Infusion pump for pain medication.
Brand
Stryker Instruments Div. of Stryker Corporation
UPC
Lot 09112926839.

Units Affected

28,755 of all pumps