Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614
FDA Recall Z-0542-2011 · Posted 2010-12-07
Recalling FirmEdwards Lifesciences Llc
Recall StatusTerminated
Product CodeDTL
Date Initiated2010-10-19
Date Terminated2011-05-18
Product Quantity322 sets
Reason for Recall
Monitoring and Infusion Set connectors may break during manipulation.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.