FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0125-06
- Recalling firm
- St. Jude Medical / Daig Division
- Product
- 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
- Status
- Terminated
- Initiated
- 2005-09-20
- Posted
- 2005-11-03
- Terminated
- 2006-07-22
- 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
- Lot, serial or model codes
- Lot 1164732
- 510(k) numbers
- ["K884494"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2182269
- Firm city
- Minnetonka
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28