Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2132-2016 — 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: 84517400546

U.S. FDA — Device Enforcement · United States · 2016-05-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2132-2016
Date of alert: 2016-05-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Lifeline First Aid LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 845174004429

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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