Z-0125-06

Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length...

Name: Z-0125-06 Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length...
Creator: St. Jude Medical / Daig Division
Published: 2005-09-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-09-20 / Terminated / root cause: labeling and UDI

FDA source

St. Jude Medical / Daig Division began a recall of 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... on 2005-09-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0125-06
Status: Terminated
Initiated: 2005-09-20
Posted: 2005-11-03
Terminated: 2006-07-22
Recalling firm: Abbott Medical
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
Product code: DYB Introducer, Catheter
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 2000
Distribution: CA, FL, KY, IL, MN, NY, OH, TN, VA & WI
Product codes and lots: Lot 1164732

Product code DYB

K884494Class IIDaig Obturator, Catheter IntroducerDaig Corp. / cleared 1989-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)