Z-2061-2019Class III

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

Name: Z-2061-2019 Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Creator: Medela Inc
Published: 2018-12-05
License: https://open.fda.gov/license/

Medela AG / initiated 2018-12-05 / Terminated / root cause: manufacturing process

FDA source

Medela Inc began a recall of Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 on 2018-12-05. FDA classified it as Class III and gives the reason as "The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2061-2019
Classification: Class III
Status: Terminated
Initiated: 2018-12-05
Posted: 2019-07-23
Terminated: 2020-08-25
Recalling firm: Medela AG
Product: Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Product code: FMF Syringe, Piston
Reason for recall: The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On 12/5/2018, Medela LLC notified distributors, medical facilities, and sales representatives a certified letter titled, "IMPORTANT: DEVICE RECALL." Instructions for distributors included the following steps: 1. Sign the form provided to confirm it was received, read and understood; 2. Identify product from the affected lots in inventory and record the quantity, including lot numbers; 3. Identify product from the affected lots that have been distributed to your Medical Facility customers and either record each customer name, address and phone number and attach to the form OR record the number of customers to whom it has been distributed to and send each customer a copy of the Medical Facility Notice of Product Recall and a copy of the Medical Facility Breast Milk Transfer Lid Recall & Product Inventory Confirmation Form; 4. Submit the completed and signed Form along with attachments to Medela LLC; 5. Upon receipt, Medella LLC will provide a Return Material Authorization (RMA) number and Medella LLC will send each of the customers on listed on the returned Form a copy of the Medical Facility Notice of Product Recall and a copy of the Medical Facility Breast Milk Transfer Lid Recall & Product Inventory Confirmation Form; and 6. Once the RMA number is received, return the affected product to Medella LLC McHenry, IL. Instructions for medical facilities included the following steps: 1. Sign the Form provided to confirm it was received, read and understood; 2. Identify product from the affected lots in inventory and record the quantity, including lot numbers; 3. Submit the completed and signed Form along with attachments to Medela LLC; 4. Upon receipt, Medella LLC will provide a Return Material Authorization (RMA) number; and 5. Once the RMA number is received, return the affected product to Medella LLC McHenry, IL. Instructions for sales representatives included the following steps: 1. Sign the form provided to confirm it was received, read and under
Quantity in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2061-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2061-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-23

Product code FMF

K161811Class IIMedela Low Dose Enteral SyringeMedela, Inc. / cleared 2017-02-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)