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U.S. Department of Health and Human Services

Class 2 Device Recall PediaLift Access Device

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  Class 2 Device Recall PediaLift Access Device see related information
Date Initiated by Firm July 03, 2019
Create Date February 02, 2020
Recall Status1 Terminated 3 on May 15, 2020
Recall Number Z-0931-2020
Recall Event ID 84591
Product Classification Bed, pediatric open hospital - Product Code FMS
Product PediaLift Access Device, Device Identifier: B751PDLFT0
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
Recalling Firm/
Manufacturer		 PediaLift LLC
181 Illinois Ave S
Mansfield OH 44905-2825
For Additional Information Contact Clayton Smeltz
724-622-1732
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 11
Distribution The products were distributed to the following US states: IN, NJ, NY, OH, and PA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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