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U.S. Department of Health and Human Services

Class 2 Device Recall P440 Portable Lift

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  Class 2 Device Recall P440 Portable Lift see related information
Date Initiated by Firm June 24, 2015
Date Posted July 27, 2015
Recall Status1 Terminated 3 on April 03, 2017
Recall Number Z-2269-2015
Recall Event ID 71376
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished); Patient lift with weight specification of 440 lbs (200 kg).

Product Usage:
The P-440 lift is a lifting aid used by health care professionals and those providing care in the home to lift, position, and transfer clients or a disabled family member. The ceiling lift makes it possible to move mobility impaired individuals with minimal strain or risk to the caregiver, while providing complete safety, dignity, and comfort for the client or family member.
Code Information All serial numbers.
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
There is a potential the sling loops may not stay attached to the carry bar hooks.
FDA Determined
Cause 2
Other
Action Prism Medical sent a Field Safety Notice to affected customers via certified first class US mail. The notice identified the affected product, problem and actions to be taken. For questions contact your local Prism Medical dealer or Prism Medical Customer Service Representative 1-800-891-6502
Quantity in Commerce 7105 lifts
Distribution Worldwide Distribution - US Nationwide and the countries of:Canada, Great Britain, Australia, South Korea, and Japan.
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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