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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1994-2016 | Class II | Terminated | Voluntary: Firm initiated |
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