—#82367

Product

Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheter, sterile, REF 0532-400-225.

FDA product code: MEB — Pump, Infusion, Elastomeric
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041585, K060258
Affected lot / code info: Lots 08136753310 through 09125933716.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada.

Timeline

Recall initiated: 2009-05-14
Posted by FDA: 2009-09-04
Terminated: 2010-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82367. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.