Z-2520-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 27, 2021
- Termination Date
- January 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,424 units
Product Description
10 ga ARS Decompression Needle, Part Number ZZ-0298
Reason for Recall
The device includes the incorrect Instructions for Use.
Distribution Pattern
Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
Code Information
Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ