WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.
This recall has been terminated (originally issued August 13, 2004).
- Company
- Boston Scientific Scimed
- Recall Initiated
- July 9, 2004
- Posted
- August 13, 2004
- Terminated
- January 5, 2007
- Recall Number
- Z-1340-04
- Quantity
- 82 units (H965402100) aa7 units (H965402100)
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.
Distribution
Inside the US only.
Lot / Code Info
6541400, 6497027, 6256357, 6153225, 6091290, 6070085, 6013424, 5943551, 5903039, 5817491, 5796751, 5726023
Root Cause
Other
Action Taken
Boston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product.
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