FDA Medical Device Recalls (openFDA)
Edwards Lifesciences Llc: Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614
- Recall number
- Z-0542-2011
- Recalling firm
- Edwards Lifesciences Llc
- Product
- Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614
- Status
- Terminated
- Initiated
- 2010-10-19
- Posted
- 2010-12-07
- Terminated
- 2011-05-18
- Reason
- Monitoring and Infusion Set connectors may break during manipulation.
- Root cause
- Employee error
- 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.
- Quantity
- 322 sets
- Distribution
- Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.
- Lot, serial or model codes
- Lot No.: 58803802, 58851054, 58881366
- 510(k) numbers
- ["K892377"]
- PMA numbers
- not on file
- Product code
- DTL
- Firm FEI
- 1713910
- Firm city
- Draper
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28