Medical Device
Manufacturing
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Z-1994-2016Class II

Universal Battery Charger II (UBC II)

The Anspach Effort, Inc. / initiated 2016-01-15 / Terminated / root cause: manufacturing process

The Anspach Effort, Inc. began a recall of Universal Battery Charger II (UBC II) on . FDA classified it as Class II and gives the reason as "The device is reported to enter safe mode and is no longer able to charge batteries". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1994-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
The Anspach Effort, Inc.
Product
Universal Battery Charger II (UBC II)
Product code
MOQ Battery, Replacement, Rechargeable
Reason for recall
The device is reported to enter safe mode and is no longer able to charge batteries.
Root cause tag
manufacturing process
FDA root cause
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
Product codes and lots
Part # 05.001.204 Serial #'s 10615 thru 12616

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1994-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1994-2016Class IITerminatedVoluntary: Firm initiated