Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.
This recall has been terminated (originally issued October 28, 2006).
- Company
- Boston Scientific Corp
- Recall Initiated
- September 21, 2006
- Posted
- October 28, 2006
- Terminated
- May 3, 2007
- Recall Number
- Z-0081-2007
- Quantity
- 80
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.
Distribution
Nationwide.
Lot / Code Info
Lot 8955327.
Root Cause
Other
Action Taken
Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product.
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