Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614
This recall has been terminated (originally issued December 7, 2010).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- October 19, 2010
- Posted
- December 7, 2010
- Terminated
- May 18, 2011
- Recall Number
- Z-0542-2011
- Quantity
- 322 sets
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Monitoring and Infusion Set connectors may break during manipulation.
Distribution
Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.
Lot / Code Info
Lot No.: 58803802, 58851054, 58881366
Root Cause
Employee error
Action Taken
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.
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