Cadillac First Aid Kit Recalled for Prescription-Only CPR Mask
Lifeline First Aid LLC is recalling Cadillac First Aid Kits because they contain a CPR mask cleared only for prescription use, not over-the-counter.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a regulatory clearance issue (prescription-only device sold OTC) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Lifeline First Aid LLC is recalling 2,975 units of the Cadillac First Aid Kit (Item #23459698). The recall is due to the inclusion of a CPR Shield with One Way Valve and Barrier Filter (mask) that is cleared only for prescription use and is not cleared for over-the-counter (OTC) use.
The affected kits were distributed in Arizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Utah, Virginia, Washington, and Wisconsin, as well as in New Zealand. The recall covers kits with the following expiration dates and lot numbers: Jan-16 (Lot 14181), Nov-16 (Lot 15077), Nov-16 (Lot 15097), Mar-17 (Lot 15278), and Oct-17 (Lot 16068).
Consumers should stop using the recalled kits and contact Lifeline First Aid LLC for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
- Manufacturer
- Lifeline First Aid LLC
- Category
- Medical Device — First Aid / CPR
- Affected units
- 2,975
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Exp Dates/Lot # Jan-16
- 14181 Nov-16
- 15077 Nov-16
- 15097 Mar-17
- 15278 Oct-17
- 16068
Distribution
Part of a larger recall action
This product is one of 2 recalled by Lifeline First Aid LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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