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U.S. Department of Health and Human Services

Class 2 Device Recall A625 lift

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  Class 2 Device Recall A625 lift see related information
Date Initiated by Firm January 30, 2017
Date Posted February 28, 2017
Recall Status1 Terminated 3 on December 04, 2017
Recall Number Z-1405-2017
Recall Event ID 76351
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical.
Code Information A6MC000110 A6M0001010 A6M0001011 A6M0001012 A6M0001013 A6M0001014 A6M0001015 A6M0001016 A6M0001017 A6M0001018 A6M0001019 A6M0001020 A6M0001021 A6M0001025 A6M0001026 A6M0001029 A6M0001022 A6M0001023 A6M0001024 A6M0001027 A6M0001028 
Recalling Firm/
Manufacturer		 ErgoSafe Products, LLC (DBA) Prism Medical
10888 Metro Ct
Maryland Heights MO 63043-2413
For Additional Information Contact Steve P. Kilburn
314-219-8614
Manufacturer Reason
for Recall		 During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely.
FDA Determined
Cause 2		 Device Design
Action The recalling firm called each customer on Jan 30, 2017 to review the recall and schedule a time for the firm to come to their facility to personally swap the recalled product for a new device. The FSNs were sent on Jan 31, 2017.
Quantity in Commerce 21
Distribution Product was distributed to MT and NV; one VA consignee.
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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