FDAClass IIIJuly 31, 2019

Breast Milk Transfer Lid for use with Oral Syringe recall: Sterility Concern

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

Why was Breast Milk Transfer Lid for use with Oral Syringe recalled?

The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Recalling firm
Medela Inc
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
Recall date
July 31, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
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