Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator su
FDA device recall Z-0125-06 · posted 2005-11-03 · Terminated
Recall details
- Recalling firm
- St. Jude Medical / Daig Division
- Reason for recall
- A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.
- Action taken
- A letter dated 09/20/05 was sent to all customers explaining the issue and instructed customers that a St. Jude Medical Representative will facilitate in the product removel process. Full credit will be issued.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 2000
- Distribution
- CA, FL, KY, IL, MN, NY, OH, TN, VA & WI
- Date initiated
- 2005-09-20
- Date posted
- 2005-11-03
- Date terminated
- 2006-07-22
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DAIG OBTURATOR, CATHETER INTRODUCER (K884494) | Daig Corp. | 1989-02-22 |