RegWardenFDA facility compliance records
Recall

Class II — Lifeline First Aid LLC

Recalling firmLIFELINE FIRST AID LLC
Registered facilityLIFELINE FIRST AID LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonFirst 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.
ProductItem # 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
Quantity3572 units of item #4042; 29,088 units of item #4043; 1,248 units of item #4037
DistributionDistributed 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.
Initiated2016-05-16
Classified2016-07-06
Terminated2017-02-22
Recall numberZ-2132-2016
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Lifeline First Aid LLC (Z-2132-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74329/

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