Z-2181-2014Class II

Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for...

Name: Z-2181-2014 Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for...
Creator: Beevers Manufacturing & Supply, Inc.
Published: 2014-07-11
License: https://open.fda.gov/license/

Beevers Manufacturing & Supply, Inc. / initiated 2014-07-11 / Terminated / root cause: manufacturing process

FDA source

Beevers Manufacturing & Supply, Inc. began a recall of Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit on 2014-07-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2181-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-11
Posted: 2014-08-10
Terminated: 2015-07-17
Recalling firm: Beevers Manufacturing & Supply, Inc.
Product: 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 code: PDH Blanket, Neonatal Phototherapy
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.
Root cause tag: manufacturing process
FDA root cause: No Marketing Application
Action: BMS is contacting their customers and requesting that distributors report the amount of affected product they have in stock, prior to returning affected product. BMS is also asking its distributors to forward the recall notification to its customers to whom affected product was sold. BMS expects those customers to also report to BMS the amount of affected product they have.
Quantity in commerce: 240 total (112/ lot 66812; 92/ lot 66813; 17/ lot 30660; and 19/ lot 67879).
Distribution: Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2181-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2181-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-10

Product code PDH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)