FDA-Device2021-09-29Class II
10 ga ARS Decompression Needle, Part Number ZZ-0298
North American Rescue LLC.
Hazard
The device includes the incorrect Instructions for Use.
Sold states
Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
Affected count
51,424 units
Manufactured in
35 Tedwall Ct, Greer, SC, United States
Products
10 ga ARS Decompression Needle, Part Number ZZ-0298
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2021Don't want to check this manually?
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