Medical device recalls Moderate risk

Lifeline First Aid LLC recalls 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.

Recall date
May 16, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2133-2016
FDA classification
Class II
Brand / firm
Lifeline First Aid LLC
Sold / distributed
Distributed in AZ, CA, CO, FL, GA, IL, KY, MD, MN, MO, MT, NE, NJ, NY, OK, OR, PA, SC, TN, UT, VA, WA, WA, and WI. Also distributed in New Zealand.

Why it was recalled

Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.

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