FDA recall Z-2520-2021

Product

10 ga ARS Decompression Needle, Part Number ZZ-0298

Reason for recall

The device includes the incorrect Instructions for Use.

Distribution

Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland

Key facts

Status

Terminated

Initiation date

2021-08-27

Report date

2021-09-29

Termination date

2024-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greer, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2021