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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Battery Charger II (UBC II)

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  Class 2 Device Recall Universal Battery Charger II (UBC II) see related information
Date Initiated by Firm January 15, 2016
Create Date June 15, 2016
Recall Status1 Terminated 3 on December 14, 2016
Recall Number Z-1994-2016
Recall Event ID 73203
Product Classification Battery, replacement, rechargeable - Product Code MOQ
Product Universal Battery Charger II (UBC II)
Code Information Part # 05.001.204 Serial #'s 10615 thru 12616
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Jennifer Breston
561-494-3673
Manufacturer Reason
for Recall		 The device is reported to enter safe mode and is no longer able to charge batteries.
FDA Determined
Cause 2		 Process design
Action DePuy Synthes sent an "Urgent Notice- Medical Device Recall (Removal) letter dated January 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informing them of the recall (removal) and asking them to return the UBC II when it display the blue flashing lights that indicate service and to contact DePuy Synthes Customer Support at 800-327-6887 option 2 for return device and arrange to repair or replacement. Any other question please contact the Complaint Handling Unit Manager at 561-494-3673.
Quantity in Commerce 1,992
Distribution USA Distribution to the states of : AR, AZ, CA, CO, FL, IL, IN, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OK, OR, PA, SC, TN, TX, VA, WA, WI and Hawaii
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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