—#95493

Product

Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, 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.: 58803802, 58851054, 58881366

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 #95493. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.