Z-2486-2010

Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects...

Name: Z-2486-2010 Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects...
Creator: Medela Inc
Published: 2010-08-06
License: https://open.fda.gov/license/

Medela AG / initiated 2010-08-06 / Terminated / root cause: packaging

FDA source

Medela Inc began a recall of Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal... on 2010-08-06. The reason FDA records is "The product sterility may be compromised due to possible pinholes in the rigid tray of the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2486-2010
Status: Terminated
Initiated: 2010-08-06
Posted: 2010-09-24
Terminated: 2011-09-07
Recalling firm: Medela AG
Product: Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; Article #67094S
Product code: HGX Pump, Breast, Powered
Reason for recall: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
Root cause tag: packaging
FDA root cause: Packaging
Action: Medela sent Important Device Recall letters dated August 6, 2010 to all direct accounts, identifying the affected product, the labeling issue, and actions to be taken by the customer. The accounts were informed that the sterility of the affected products may be compromised due to holes in the packaging. They were instructed to stop use, sale and distribution of the kits and return their stocks to Stericycle using the enclosed packing slip and prepaid UPS Return Service shipping label. The accounts were requested to complete and return the enclosed postage paid reply card, indicating the amount of product being returned. Distributors were requested to notify their customers. Questions about the recall process may be directed to Stericycle at 1-877-247-9970. Information on the recall is posted on Medela's website www.medelabreastfeedingus.com
Quantity in commerce: 1,293,304 kits
Distribution: Worldwide Distribution: Nationwide throughout USA, including Guam, and to the countries of Barbados, Bermuda, British West Indies, Canada, Panama, Switzerland, Trinidad and Tobago, and Uganda.
Product codes and lots: article #67094S, al lot numbers

Product code HGX

K875300Class IIMedela Breast-Pump LactinaMedela, Inc. / cleared 1988-04-06

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)