Recall Z-0125-06 ยท DYB Introducer, Catheter
St. Jude Medical / Daig Division
Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA
| Date | Nov 3, 2005 (initiated Sep 20, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 2000 |
| Distribution | CA, FL, KY, IL, MN, NY, OH, TN, VA & WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884494 | DAIG OBTURATOR, CATHETER INTRODUCER Daig Corp., Feb 22, 1989 |