FDA-Device2022-04-13Class II

Lum Lam Custom Pack - Anesthesia Kit

Stradis Medical, LLC dba Stradis Healthcare
Hazard

The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.

Sold states
US Nationwide distribution in the states of IN, TX, and PA.
Affected count
21 units
Manufactured in
3025 Northwoods Pkwy, Peachtree Corners, GA, United States
Products
Lum Lam Custom Pack - Anesthesia Kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0863-2022

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