Recall Z-2061-2019 ยท FMF Syringe, Piston
Medela Inc
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
| Date | Dec 5, 2018 |
| Status | Terminated |
| Reason | The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. |
| Root 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 num |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161811 | Medela Low Dose Enteral Syringe Medela, Inc., Feb 15, 2017 |