Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Recall
- Recall Number
- Z-2061-2019
- Event Number
- 81779
- Firm
- Medela Inc
- FEI Number
- 1419937
- Product Code
- FMF
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- December 5, 2018
- Terminated
- August 25, 2020
- Address
- 1101 Corporate Dr, McHenry, IL, 60050-7006
Description
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
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
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
665,600 lids (6,656 cases)