Sterile double breast personal accessory convenience kit for the Symphony Breast pump; the kit connects to a hospital gr

FDA device recall Z-2483-2010 · posted 2010-09-24 · Terminated

Recall details

Recalling firm

Medela Inc

Reason for recall

The product sterility may be compromised due to possible pinholes in the rigid tray of the package.

Action taken

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

Root cause

Packaging

Status

Terminated

Product code

HGX

Quantity affected

581,296 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.

Date initiated

2010-08-06

Date posted

2010-09-24

Date terminated

2011-09-07

Location

Mchenry, IL

Related 510(k) clearances