FDA Recall
Terminated
The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set.
Recall: Z-0408-03
·
Initiated November 8, 2002
Recall
- Recall Number
- Z-0408-03
- Event Number
- 25052
- Firm
- Nipro Corp
- FEI Number
- 1000132332
- Product Code
- FIE
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 8, 2002
- Posted
- May 21, 2003
- Terminated
- April 15, 2008
- Address
- 3150 NW 107th Avenue Brokers Box 97, Miami, FL, 33172
Description
The following brand name labeled products are under recall (all catalog numbers and all lot numbers under recall): NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula Set and EXEL Secure Touch Safety AV Fistula Needle Set.
Reason
Air or fluid leakage at the hub/needle junction.
Action
The recall letters were mailed on November 8, 2002 to direct accounts and requested subrecall down to the health professional/clinic level. It was requested that Nipro be notified of all held and recovered product for pickup. Also new replacement product will be made available in the near future.
Distribution
Nationwide and Canada
Quantity
6,984,000