Class 3 Device Recall Breast Milk Transfer Lid

• Date Initiated by Firm: December 05, 2018
• Create Date: July 23, 2019
• Recall Status: Terminated on August 25, 2020
• Recall Number: Z-2061-2019
• Recall Event ID: 81779
• 510(K)Number: K161811
• Product Classification: Syringe, piston - Product Code FMF
• Product: Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
• Code Information: Model Number: 90003S-100; Lot codes: 441113, 441825, 441965, 442099, 442188, 442494, 442612, 443265, 443557, 444054, 444317, 445260, 445310, 445470, 445678, 446402, 446518, 446916, 447447, 447470, 447789.
• FEI Number: 1419937
• Recalling Firm/ Manufacturer: Medela Inc; 1101 Corporate Dr; McHenry IL 60050-7006
• For Additional Information Contact: Jan Kloiber; 815-578-2295
• Manufacturer Reason for Recall: The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
• FDA Determined Cause: Equipment maintenance
• Action: On 12/5/2018, Medela LLC notified distributors, medical facilities, and sales representatives a certified letter titled, "IMPORTANT: DEVICE RECALL." Instructions for distributors included the following steps: 1. Sign the form provided to confirm it was received, read and understood; 2. Identify product from the affected lots in inventory and record the quantity, including lot numbers; 3. Identify product from the affected lots that have been distributed to your Medical Facility customers and either record each customer name, address and phone number and attach to the form OR record the number of customers to whom it has been distributed to and send each customer a copy of the Medical Facility Notice of Product Recall and a copy of the Medical Facility Breast Milk Transfer Lid Recall & Product Inventory Confirmation Form; 4. Submit the completed and signed Form along with attachments to Medela LLC; 5. Upon receipt, Medella LLC will provide a Return Material Authorization (RMA) number and Medella LLC will send each of the customers on listed on the returned Form a copy of the Medical Facility Notice of Product Recall and a copy of the Medical Facility Breast Milk Transfer Lid Recall & Product Inventory Confirmation Form; and 6. Once the RMA number is received, return the affected product to Medella LLC McHenry, IL. Instructions for medical facilities included the following steps: 1. Sign the Form provided to confirm it was received, read and understood; 2. Identify product from the affected lots in inventory and record the quantity, including lot numbers; 3. Submit the completed and signed Form along with attachments to Medela LLC; 4. Upon receipt, Medella LLC will provide a Return Material Authorization (RMA) number; and 5. Once the RMA number is received, return the affected product to Medella LLC McHenry, IL. Instructions for sales representatives included the following steps: 1. Sign the form provided to confirm it was received, read and under
• Quantity in Commerce: 665,600 lids (6,656 cases)
• Distribution: Nationwide distribution in IL, MO, NE, OH, RI, TN, TX, VA. International distribution in Canada Internal Medela and sales reps located in CA, CO, IL, LA, NC, NJ, NV, PA, SC, TN, TX Domestic Hospitals located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI
• 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 = FMF