Z-0931-2020 Class II Terminated
FDA device recall Z-0931-2020 was initiated by PediaLift LLC on July 3, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 15, 2020). Affected quantity: 11.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- July 3, 2019
- Termination Date
- May 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
PediaLift Access Device, Device Identifier: B751PDLFT0
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.
Distribution Pattern
The products were distributed to the following US states: IN, NJ, NY, OH, and PA
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