PlainRecalls
FDA Devices Moderate Class II Terminated

10 ga ARS Decompression Needle, Part Number ZZ-0298

Reported: September 29, 2021 Initiated: August 27, 2021 #Z-2520-2021

Product Description

10 ga ARS Decompression Needle, Part Number ZZ-0298

Reason for Recall

The device includes the incorrect Instructions for Use.

Details

Units Affected
51,424 units
Distribution
Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
Location
Greer, SC

Frequently Asked Questions

What product was recalled?
10 ga ARS Decompression Needle, Part Number ZZ-0298. Recalled by North American Rescue LLC.. Units affected: 51,424 units.
Why was this product recalled?
The device includes the incorrect Instructions for Use.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2520-2021.