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

FDA Recall #Z-2061-2019 — Class III — December 5, 2018

Recall #Z-2061-2019 Date: December 5, 2018 Classification: Class III Status: Terminated

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.

Recalling Firm

Medela Inc — McHenry, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product 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, 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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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