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

FDA device recall Z-2181-2014 · posted 2014-08-10 · Terminated

Recall details

Recalling firm

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.

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

PDH

Quantity affected

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.

Date initiated

2014-07-11

Date posted

2014-08-10

Date terminated

2015-07-17

Location

McMinnville, OR