Recalls / —
—#82407
Product
Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr with 2.5 in. antimicrobial silver ExFen catheter, sterile, REF 8531-200-025.
- FDA product code
- MEB — Pump, Infusion, Elastomeric
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K041585, K060258
- Affected lot / code info
- Lot 09111920718.
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 #82407. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.