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Recall Observatory FDA recall evidence

Device product

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

Z-2133-2016

May 16, 2016

Class II

Product summary

Firm
Lifeline First Aid LLC
Event
Event 74329
Status
Terminated
Classification
Class II
Quantity
2975 kits
Official record key
device-enforcement:Z-2133-2016

Official wording

Reason: 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.

Code information: Exp Dates/Lot # Jan-16; 14181 Nov-16; 15077 Nov-16; 15097 Mar-17; 15278 Oct-17; 16068

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.