Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1336-2014Class II

Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model...

Energizer Personal Care / initiated 2014-03-18 / Terminated

Energizer Personal Care began a recall of Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package on . FDA classified it as Class II and gives the reason as "Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1336-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Energizer Personal Care
Product
Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package.
Product code
HGX Pump, Breast, Powered
Reason for recall
Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.
FDA root cause
Component change control
Action
Energizer sent and Voluntary Retail Recall Notice letter dated March 18, 2014 to retail customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to stop sale and return the affected product. The letter provides instruction to customers to return the affected product. For questions or concerns, contact Energizer Personal Care at 1-888-207-1492 or visit www.playtexproducts.com. On 9/9/2014 the firm expanded the recall to one additional production lot to include: Suspect date codes for Breast Pumps: P12315-XXXX to P13205-XXXX. Suspect adaptor date codes: 1238 to 1324 Revised Press issued 9/9/2014.
Quantity in commerce
35,803
Distribution
USA Nationwide Distribution in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, ON, OR, PA, SC, TN, TX, VA, VT, WA, WI Canada - one consignee, Energizer (recalling firm's) company store
Product codes and lots
Suspect date codes for Breast Pumps: P12324-91667C to P13205-30673C. Suspect adaptor date codes: 1241 to 1324. 9/9/2014 Expanded recall: Suspect date codes for Breast Pumps: P12315-XXXX to P13205-XXXX. Suspect adaptor date codes: 1238 to 1324.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1336-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1336-2014Class IITerminatedVoluntary: Firm initiated