Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwa
FDA device recall Z-0542-2011 · posted 2010-12-07 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Llc
- Reason for recall
- Monitoring and Infusion Set connectors may break during manipulation.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DTL
- Quantity affected
- 322 sets
- Distribution
- Nationwide Distribution: in the states of FL, KS, MO, TX, VA, and PR.
- Date initiated
- 2010-10-19
- Date posted
- 2010-12-07
- Date terminated
- 2011-05-18
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET (K892377) | Research Medical, Inc. | 1989-12-07 |