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

Recall Z-2181-2014 — Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.

U.S. FDA — Device Enforcement · United States · 2014-07-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2181-2014
Date of alert
2014-07-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beevers Manufacturing & Supply, Inc.
Product category
device
Product type
Devices
Reported risk: Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.
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.

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