• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Universal Pumping Kit (Sterile)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Universal Pumping Kit (Sterile) see related information
Date Initiated by Firm August 06, 2010
Date Posted September 24, 2010
Recall Status1 Terminated 3 on September 07, 2011
Recall Number Z-2485-2010
Recall Event ID 56498
510(K)Number K875300  K801862  K823840  
Product Classification Pump, breast, powered - Product Code HGX
Product Sterile single/double breast personal accessory convenience kit for single or double pumping with a Classic 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 #67093S
Code Information article #67093S, al lot numbers
Recalling Firm/
Medela Inc
1101 Corporate Dr
Mchenry IL 60050-7006
For Additional Information Contact Mr. Samuel B. Levey
Manufacturer Reason
for Recall
The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
FDA Determined
Cause 2
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 3,019,835 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HGX and Original Applicant = MEDELA, INC.