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.
This recall has been terminated (originally issued March 25, 2006).
- Company
- St. Jude Medical Daig Division
- Recall Initiated
- August 22, 2005
- Posted
- March 25, 2006
- Terminated
- July 22, 2006
- Recall Number
- Z-0677-06
- Quantity
- 4160
- Firm Location
- Minnetonka, MN
- Official Source
- View on FDA website ↗
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.
Distribution
International Only-Belgium, China, Guadalajara, New Zealand and Thailand.
Lot / Code Info
Lot number 1146548
Root Cause
Other
Action Taken
Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.
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