Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
This recall has been terminated (originally issued September 13, 2006).
- Company
- Boston Scientific Corp
- Recall Initiated
- August 10, 2006
- Posted
- September 13, 2006
- Terminated
- February 7, 2007
- Recall Number
- Z-1499-06
- Quantity
- 4 units
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge.
Distribution
Texas.
Lot / Code Info
Lot 8606405; exp. March 31, 2009.
Root Cause
Other
Action Taken
Consignee was notified via letter 8/10/06 to discontinue use of the product and to return it to the firm.
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