Item # 4042-CPR Rescue Kit — Class II medical device recall Z-2132-2016
Terminated recall by Lifeline First Aid LLC, reported 2016-07-13, distributed in AZ, CA, CO, FL, GA, IL, KY, MD…. First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier
| Recall number | Z-2132-2016 |
|---|---|
| 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 |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00845174003453, 00845174004429, 00845174004436, 00845174005464, 00845174005471, 00845174005594, 00845174005600 |
| Lot numbers | 1/16, 1/17, 10/16, 101483, 101546, 101682, 101804, 101812, 102032, 102098, 102109, 102130, 102295, 102296, 102317, 102372, 102638, 102694, 3/15, 5/16, 5/17, 6/15, 7/15, 8/17 |
| Model numbers | 4037, 4042, 4042-CPR, 4043, 4043-CPR |
| Expiration dates | 2017-11-30 |
Product
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; UPC Lime color kit: 845174005594; UPC Purple color: 845174005600; UPC of master case of 6 845174005471 (2 each color) Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
Reason for recall
First aid kits or rescue kits are recalled because they 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-2132-2016. 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.