Class 2 Device Recall Contact Nipple Shield (Sterile) 24mm (Standard)

• Date Initiated by Firm: May 18, 2011
• Date Posted: June 10, 2011
• Recall Status: Terminated on February 16, 2012
• Recall Number: Z-2553-2011
• Recall Event ID: 58730
• Product Classification: Shield, nipple - Product Code HFS
• Product: Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S ; ; Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.
• Code Information: article number 67203S, lot numbers 358789, 359716, 360440, 360632, 364515, 366388, 366492, 366570, 366682, 366702, 366705, and 366806.
• Recalling Firm/ Manufacturer: Medela Inc; 1101 Corporate Dr; Mchenry IL 60050-7006
• For Additional Information Contact: Mr. Donald J. Alexander; 815-578-2406
• Manufacturer Reason for Recall: The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
• FDA Determined Cause: Packaging
• Action: The firm, Medela, sent an "Important Device Recall" letter dated May 9, 2011 to all of their customers/direct accounts. Medala also began telephoning or visiting the direct accounts/customers on May 18, 2011. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lots and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form inlcude with this letter 4) complete and return the Product Inventory Form via fax to 800-995-7867 or email jim.hughes@medela.com, even if they have no affected product on hand 5)If you have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. Each affected product will be replaced with (2) non-sterile nipple shields. 5) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. Questions about the recall process were directed to Medela Customer Service at 1-888-835-5968 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to notify their customers of the recall, using the enclosed customer letter.
• Quantity in Commerce: 4,320 units
• Distribution: Nationwide distribution: USA including states of: AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, MA, MD, ME,MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TX, UT, VA, VT, WA, WI, and WV.
• 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.