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Pump in Style Advanced (PNSA)Breast Pump recallZ-1224-2011 · Medela Inc · initiated Jan 10, 2011

Terminated All recalls posted in February 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medela Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Vendor change control

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-1224-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 10, 2011
Posted by the FDA
Feb 11, 2011
Recalling firm
Medela Inc
Quantity
11,154 units
Product code
HGX
FDA submissions
K031614
Distribution
Nationwide, including Puerto Rico

Product description

Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag Tagged; d) article 57043 - PNSA without kit; e) article 57062 - Kit PNSA Backpack; f) article 57062-03 - Kit PNSA Backpack CA/3; g) article 57062T - Kit PNSA Backpack Tagged; h) 57102 - Motor Replacement PNSA Backpack 57062; i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.

Code information (models, lots, serial numbers)

manufacture dates 02/10/10 through 03/03/10

Other devices under the same FDA submission

7 devices cleared under K031614 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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