The Recall Desk

FDA (Devices) recall action 74329

Lifeline First Aid LLC recalled 2 products on 2016-07-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-07-13
Critical
0
Units
2,975

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-07-13

    Lifeline CPR Rescue Kits Recalled for Prescription-Only Mask Component

    Lifeline First Aid LLC is recalling CPR rescue kits because the included CPR shield mask is cleared only for prescription use, not over-the-counter.

    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 col
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2016-07-13

    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.

    Product
    5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
    Category
    Distribution
    23 states