Recalls / —
—#95494
Product
Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.
- FDA product code
- DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K892377
- Affected lot / code info
- Lot No.: 58832055, 58896850, 58916757
Why it was recalled
Monitoring and Infusion Set connectors may break during manipulation.
Root cause (FDA determination)
Employee error
Action the firm took
Edwards Lifesciences issued a Urgent Product Recall letter dated October 13, 2010 to customers identifying the affected devices, requesting the return of unused devices and completion and return of a response form. Further information is available at 800-424-3278.
Recalling firm
- Firm
- Edwards Lifesciences Llc
- Address
- 12050 Lone Peak Parkway, Draper, Utah 84020-9414
Distribution
- Distribution pattern
- Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.
Timeline
- Recall initiated
- 2010-10-19
- Posted by FDA
- 2010-12-07
- Terminated
- 2011-05-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #95494. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.