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Recall Observatory FDA recall evidence

Device product

Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100

Z-2061-2019

December 05, 2018

Class III

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

    reason.sterility_assurance · v1.0.0

    sterility may be compromised