Recall Z-0931-2020 ยท FMS Bed, Pediatric Open Hospital
PediaLift LLC
PediaLift Access Device, Device Identifier: B751PDLFT0
| Date | Jul 3, 2019 |
| Status | Terminated |
| Reason | The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling requirements. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were contacted via email on 7/3/19. Customers were instructed to respond to the email so that replacement mattresses could be shipped. Letters dated 11/26/19 accompanied the replacement mattresses sent to customers. The letter instructed customers to please be advised that you must immediately dispose of the old mattress and utilize this replacement mattress. If you have any questions regarding this matter, feel free to contact us. Thank you, Jillena Atchison Jillena@PediaLift.com 724-417-9180 |
| Quantity | 11 |
| Distribution | The products were distributed to the following US states: IN, NJ, NY, OH, and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.