Device product
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Z-2061-2019
Product summary
- Firm
- Medela Inc
- Event
- Event 81779
- Status
- Terminated
- Classification
- Class III
- Quantity
- 665,600 lids (6,656 cases)
- Official record key
device-enforcement:Z-2061-2019
Official wording
Reason: The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
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.
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
Derived failure modes
-
Sterility assurance
sterility may be compromised