Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St.
FDA device recall Z-0677-06 · posted 2006-03-25 · Terminated
Recall details
- Recalling firm
- St. Jude Medical / Daig Division
- 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.
- Action taken
- Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.
- Root cause
- Other
- Status
- Terminated
- Product code
- MGB
- Quantity affected
- 4160
- Distribution
- International Only-Belgium, China, Guadalajara, New Zealand and Thailand.
- Date initiated
- 2005-08-22
- Date posted
- 2006-03-25
- Date terminated
- 2006-07-22
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.