Recall Z-2035-2024— Avanos Medical, Inc.

Name: FDA recall Z-2035-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-04

Class III · Ongoing

Class III FDA medical device recall by Avanos Medical, Inc., initiated 2024-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonSterile, Product Code BA-S60EO; h. 6mL Oral Syringe Amber NonSterile, Product Code BA-S6EO;. Reason: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers..

Recalling firm: Avanos Medical, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2024-03-04
Firm location: Alpharetta, GA, United States

Product description

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonSterile, Product Code BA-S60EO; h. 6mL Oral Syringe Amber NonSterile, Product Code BA-S6EO;

Reason for recall

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

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