FDA Recall
Terminated
NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.
Recall: Z-0599-2016
·
Initiated April 1, 2014
Recall
- Recall Number
- Z-0599-2016
- Event Number
- 72707
- Firm
- Nipro Medical Corporation
- FEI Number
- 1000132332
- Product Code
- FOZ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 1, 2014
- Terminated
- December 14, 2016
- Address
- 3150 Nw 107th Ave, Miami, FL, 33172
Description
NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC.
Reason
Device has the potential to have torn wings.
Action
The only one Distributor was notified (2014) by e-mail by the firm of the quality deficiency before the product arrived at their facility. It was immediately returned to Nipro Medical when it arrived.
Distribution
US distribution including TN.
Quantity
160,000 pieces.