Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000).
This recall has been terminated (originally issued August 2, 2006).
- Company
- Boston Scientific Corp
- Recall Initiated
- June 2, 2006
- Posted
- August 2, 2006
- Terminated
- April 17, 2007
- Recall Number
- Z-1308-06
- Quantity
- 22 kits.
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The packages are labeled sterile, but the product was not sterilized.
Distribution
Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin.
Lot / Code Info
Lots 8555778, 8552615 and 8718072.
Root Cause
Other
Action Taken
Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products.
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