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Recall Observatory FDA recall evidence

Device product

PediaLift Access Device, Device Identifier: B751PDLFT0

Z-0931-2020

July 03, 2019

Class II

Product summary

Firm
PediaLift LLC
Event
Event 84591
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-0931-2020

Official wording

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.

Code information: Serial Numbers: PCL-HDPE-DL-1, PCL-HDPE-DL-2, PCL-HDPE-DL-3, PCL-HDPE-DL-4, PCL-HDPE-DL-5, PCL-HDPE-DL-6, PCL-HDPE-DL-7, PCL-HDPE-DL-8, PCL-HDPE-DL-9, PCL-HDPE-DL-10, PCL-HDPE-DL-11, PCL-HDPE-DL-12

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.