5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
FDA Recall Z-2133-2016 · Posted 2016-07-06
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Recalling FirmLifeline First Aid LLC
Recall StatusTerminated
Product CodeCBP
Date Initiated2016-05-16
Date Terminated2017-02-22
Product Quantity2975 kits
Reason for Recall
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.
Firm Action
The firm sent the PRODUCT RECALL NOTICE- LIFELINE FIRST AID KITS WHICH INCLUDE CPR MASK letter, dated 5/11/2016, to their consignees.
CPR shields will be replaced without charge and acceptable Lifeline First Aid kits will be re-worked and returned using our standard RGA process.
In addition, the firm sent the PRODUCT RECALL NOTICE- CADILLAC FIRST AID KIT letter, dated May 31, 2016, to General Motors. General Motors will be sending out a dealership bulletin to inform their customers of this issue. Once confirmed, replacement masks will be sent to the requested dealerships and made available to be ordered (at no cost) as needed.
Please complete and fax the attached Customer Response Form to Lifeline at (503)783-3721.
Consignees with questions should call Lifeline First Aid, LLC at (503)783-3660.
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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