Z-0599-2016 Class III Terminated
FDA device recall Z-0599-2016 was initiated by Nipro Medical Corporation on April 1, 2014 and is designated Class III. Reason for recall: Device has the potential to have torn wings. The recall status is terminated (terminated December 14, 2016). Affected quantity: 160,000 pieces..
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2016
- Initiation Date
- April 1, 2014
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160,000 pieces.
Product Description
NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.
Reason for Recall
Device has the potential to have torn wings.
Distribution Pattern
US distribution including TN.
Code Information
Model No.: FS+173230BC, Lot #14A22 and Lot #14A26.