Recall Z-2061-2019— Medela Inc

Name: FDA recall Z-2061-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-05

Class III · Terminated

Class III FDA medical device recall by Medela Inc, initiated 2018-12-05, terminated 2020-08-25. It names one FDA 510(k) clearance: K161811. Product: Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100. Reason: The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact..

Recalling firm: Medela Inc
Classification: Class III
Status: Terminated
Initiated: 2018-12-05
Terminated: 2020-08-25
Firm location: McHenry, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K161811 — Medela Low Dose Enteral SyringeMedela, Inc.·cleared 2017-02-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.