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Terminated

PediaLift Access Device, Device Identifier: B751PDLFT0

FDA Recall Z-0931-2020 · Posted None

Recalling FirmPediaLift LLC
Recall StatusTerminated
Product CodeFMS
Date Initiated2019-07-03
Date Terminated2020-05-15
Product Quantity11

Reason for Recall

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.

Firm 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 [email protected] 724-417-9180

Root Cause

Nonconforming Material/Component

Distribution Pattern

The products were distributed to the following US states: IN, NJ, NY, OH, and PA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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