Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LL
FDA device recall Z-0992-2011 · posted 2011-01-28 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Llc
- Reason for recall
- Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.
- Action taken
- The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated December 3, 2010 to customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to check their inventory and return the unused devices; complete and return the INTROCSC Introducer Recall Response form to the attention of Customer Service, Edwards LifeSciences, One Edwards Way, Irvine, CA at 949-250-3489. If you have any questions, please contact Edwards Customer Service at 800-424-3278 from 8:00am - 4:30pm Pacific Time.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 90 kits
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-12-03
- Date posted
- 2011-01-28
- Date terminated
- 2011-10-27
- 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 |
|---|---|---|
| CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER (K023880) | ETHICON, Inc. | 2002-12-11 |