Recall Z-2181-2014 ยท PDH Blanket, Neonatal Phototherapy
Beevers Manufacturing & Supply, Inc.
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
| Date | Aug 10, 2014 (initiated Jul 11, 2014) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.