Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and LW105 (extra large), Lot 67879. LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Beevers Manufacturing & Supply, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Product Codes/Lot Numbers:
Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and LW105 (extra large), Lot 67879. LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2181-2014
Related Recalls
Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
Cannulaide recalled May 2008 due to improper seal of the pouch. The improper seal of the Cannulaide's package could potentially affect the device shelf life.