| Class 2 Device Recall EVA 450 Patient Lift Battery Charger | |
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
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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
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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 |
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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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