Z-0677-06

Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single...

Name: Z-0677-06 Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single...
Creator: St. Jude Medical / Daig Division
Published: 2005-08-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-08-22 / Terminated / root cause: packaging

FDA source

St. Jude Medical / Daig Division began a recall of Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc... on 2005-08-22. The reason FDA records is "Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0677-06
Status: Terminated
Initiated: 2005-08-22
Posted: 2006-03-25
Terminated: 2006-07-22
Recalling firm: Abbott Medical
Product: Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.
Product code: MGB Device, Hemostasis, Vascular
Reason for recall: Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.
Root cause tag: packaging
FDA root cause: Other
Action: Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.
Quantity in commerce: 4160
Distribution: International Only-Belgium, China, Guadalajara, New Zealand and Thailand.
Product codes and lots: Lot number 1146548

Product code MGB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)