Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
FDA Device Recall #Z-2061-2019 — Class III — December 5, 2018
Recall Summary
| Recall Number | Z-2061-2019 |
| Classification | Class III — Low risk |
| Date Initiated | December 5, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medela Inc |
| Location | McHenry, IL |
| Product Type | Devices |
| Quantity | 665,600 lids (6,656 cases) |
Product Description
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Reason for Recall
The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
Distribution Pattern
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
Lot / 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.
Other Recalls from Medela Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0773-2020 | Class II | Invia Foam Dressing Kit with FitPad - X-Large (... | Dec 2, 2019 |
| Z-2528-2018 | Class II | Invia Motion Negative Pressure Wound Therapy Sy... | Feb 7, 2018 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.