Device product
10 ga ARS Decompression Needle, Part Number ZZ-0298
Z-2520-2021
Product summary
- Event
- Event 88603
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51,424 units
- Official record key
device-enforcement:Z-2520-2021
Official wording
Reason: The device includes the incorrect Instructions for Use.
Code information: Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ
Distribution pattern: Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
Derived failure modes
-
Unknown
The device includes the incorrect Instructions for Use.