Z-2061-2019 Class III Terminated
FDA device recall Z-2061-2019 was initiated by Medela Inc on December 5, 2018 and is designated Class III. Reason for recall: The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. The recall status is terminated (terminated August 25, 2020). Affected quantity: 665,600 lids (6,656 cases).
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- December 5, 2018
- Termination Date
- August 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
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.