5195GM — Class II medical device recall Z-2133-2016
Terminated recall by Lifeline First Aid LLC, reported 2016-07-13, distributed in AZ, CA, CO, FL, GA, IL, KY, MD…. Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (m
| Recall number | Z-2133-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lifeline First Aid LLC, Wilsonville, OR, United States |
| Recall initiated | 2016-05-16 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2017-02-22 |
| Distributed | AZ, CA, CO, FL, GA, IL, KY, MD, MN, MO, MT, NE, NJ, NY, OK, OR, PA, SC, TN, UT, VA, WA, WI |
| Countries outside the US | NZ |
| Quantity | 2,975 kits |
| Reason classes | unapproved product |
| Lot numbers | 14181, 15077, 15097, 15278, 16068, JAN-16, MAR-17, NOV-16, OCT-17 |
Product
5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2133-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.