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U.S. Department of Health and Human Services

Class 2 Device Recall Carry bar

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  Class 2 Device Recall Carry bar see related information
Date Initiated by Firm August 30, 2016
Create Date December 09, 2016
Recall Status1 Terminated 3 on July 18, 2018
Recall Number Z-0728-2017
Recall Event ID 74488
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
Code Information There are no lot numbers, serial numbers, or UPC codes, only the model numbers.  Model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
Recalling Firm/
Manufacturer		 ErgoSafe Products, LLC (DBA) Prism Medical
10888 Metro Ct
Maryland Heights MO 63043-2413
For Additional Information Contact Steve P. Kilburn
866-891-6502
Manufacturer Reason
for Recall		 The black plastic puck on the carry bar is breaking resulting in potential for patient harm.
FDA Determined
Cause 2		 Device Design
Action The recalling firm sent field safety notices to their customers by mail on August 30, 2016. The notice instructed customers to inspect their carry bar to see if it used a black plastic puck. If it did, they were instructed to contact the recalling firm to receive a metal insert to install. If the puck is cracked or damaged, they can request a new, replacement carry bar at a discounted price. For further questions, please call (866) 891-6502.
Quantity in Commerce not greater than 17,964 units
Distribution Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea
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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