Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusive

FDA device recall Z-1224-2011 · posted 2011-02-11 · Terminated

Recall details

Recalling firm

Medela Inc

Reason for recall

The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.

Action taken

This firm, Medela, sent an "Important Device Recall" letter dated January 11, 2011 to all of direct accounts via UPS or US Mail. The accounts were informed that a component on the control board, after a period of usage, may cause the motor to slow down or stop, resulting one or more of the following symptoms: the pump will not turn on; the pump turns off on its own; the pump reduces or loses suction during the pumping process or the pump is making a clicking noise. If the users have a pump that exhibits any of these symptoms, they were requested to visit Medela's website at www.medelareturns.com to expedite shipment of a replacement unit. Questions about the recall process were directed to Medela Customer Service at 1-800-435-8316 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to post the recall notice within their establishment visible to their customer base, and to notify their customers of the recall. Information on the recall was posted on Medela's website www.medelareturns.com on January 11, 2011.

Root cause

Vendor change control

Status

Terminated

Product code

HGX

Quantity affected

11,154 units

Distribution

Nationwide, including Puerto Rico

Date initiated

2011-01-10

Date posted

2011-02-11

Date terminated

2012-05-21

Location

Mchenry, IL

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