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U.S. Department of Health and Human Services

Class 2 Device Recall EVA 450 Patient Lift Battery Charger

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  Class 2 Device Recall EVA 450 Patient Lift Battery Charger see related information
Date Initiated by Firm April 28, 2010
Date Posted June 01, 2010
Recall Status1 Terminated 3 on September 30, 2010
Recall Number Z-1736-2010
Recall Event ID 55659
Product Classification Non-AC-powered patient lift. - Product Code FSA
Product EVA 450 Patient Lift Battery Charger.
Code Information Serial numbers: 373317696102209, 373317696102210, 373317696102224, 373317696102227, 373317696102228, 373317696102232, 373317696102235, 373317696102242, and 373317696102244.
Recalling Firm/
Manufacturer		 Romedic, Inc.
300 West Chestnut St.
Po Box 388
Ephrata PA 17522
For Additional Information Contact Joe Chestnut
888-625-4343
Manufacturer Reason
for Recall		 Incorrect battery chargers were supplied with the EVA 450 Patient Lifts. Charger unit stops working and will not charge lift. New chargers were supplied to customers.
FDA Determined
Cause 2		 Other
Action The recalling firm sent out a letter with instructions as follows: 1) Locate EVA 450 Patient Lift(s), 2) Fill out Customer Response Form and fax to 888-691-1091, 3) Replace battery charger(s) with new battery charger(s) supplied with this notification; NEW battery charger to be used according to EVA 450 Instructions, 4) Repackage replaced battery charger(s) in original packing in which shipment was recieved, 5) Apply supplied sticker "EVA 450 Battery Charger RECALL" on outside of box, 6) Apply supplied UPS return label on outside of box and contact UPS for pickup and mail to the following Address: RoMedic, Inc., 300 West Chestnut St., Ephrata, PA 17522; Attn: EVA 450 Battery Charger Recall. Additional questions are directed to the company at phone: 888-625-4343.
Quantity in Commerce 76 units
Distribution Nationwide distribution.
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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