Z-1442-2010

Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive...

Name: Z-1442-2010 Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive...
Creator: Medela Inc
Published: 2010-03-15
License: https://open.fda.gov/license/

Medela AG / initiated 2010-03-15 / Terminated / root cause: labeling and UDI

FDA source

Medela Inc began a recall of Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged... on 2010-03-15. The reason FDA records is "The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1442-2010
Status: Terminated
Initiated: 2010-03-15
Posted: 2010-04-27
Terminated: 2010-12-10
Recalling firm: Medela AG
Product: Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: a) Model 67023, Harmony to Symphony Conversion Kit; b) Model 67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099, Symphony Retail Kit; d) Model 67099-06, Symphony Retail Kit - case of 6 kits; e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;
Product code: HGX Pump, Breast, Powered
Reason for recall: The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: An "IMPORTANT:DEVICE RECALL" letter dated March 12, 2010 to the the customers on March 15, 2010, via certified mail, return receipt requested. The letters were tailored to each customer listing the affected shipments sent to them, and informing them of the labeling insert problem. The customers were requested to cease distribution of the affected kits and return them to the firm (Medela) for replacement, and if applicable, to notify their retail customers. The customers were instructed to call Medela Customer Service at 877-320-2301 for assistance in processing returns or for further clarification on the recall.
Quantity in commerce: 13,834 kits
Distribution: Nationwide distribution
Product codes and lots: item #1908095, revision B 0909, contained in kits shipped between 10/23/09 and 02/02/2010

Product code HGX

K020518Class IIMedela Symphony Breast Pump, Model 024Medela, Inc. / cleared 2002-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)