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
- Company
- St. Jude Medical Daig Division
- Recall Initiated
- September 20, 2005
- Posted
- November 3, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0125-06
- Quantity
- 2000
- Firm Location
- Minnetonka, MN
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.
Distribution
CA, FL, KY, IL, MN, NY, OH, TN, VA & WI
Lot / Code Info
Lot 1164732
Root Cause
Other
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.
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