Z-2035-2024Class III

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe...

Name: Z-2035-2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe...
Creator: Avanos Medical, Inc.
Published: 2024-03-04
License: https://open.fda.gov/license/

Halyard Health / initiated 2024-03-04 / Open, Classified / root cause: labeling and UDI

FDA source

Avanos Medical, Inc. began a recall of NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral... on 2024-03-04. FDA classified it as Class III and gives the reason as "The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2035-2024
Classification: Class III
Status: Open, Classified
Initiated: 2024-03-04
Posted: 2024-06-07
Recalling firm: Halyard Health
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;
Product code: KYX Dispenser, Liquid Medication
Reason for recall: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Avanos notified consignees via email or overnight FedEx on or about 03/04/2024. Consignees were instructed to locate affected product in their inventories by comparing the case packaging as demonstrated in the letters, and destroying it. An acknowledgment form was provided in order for them to record their inventory, and confirm destruction, to be returned to [email protected]. Replacement with unaffected Avanos NeoMed* Pharmacy Syringes Nonsterile (Non ENFit) will be provided to end users who report affected inventory. Distributors are asked to identify their affected customers and provide notification to them, as well as report theirs and their customers inventory to Avanos via the acknowledgment form.
Quantity in commerce: 37,476 cases (16,704,600 units)
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
Product codes and lots: a. UDIDI 00350770002798, all lot numbers; b. UDIDI 00350770002835, all lot numbers; c. UDIDI 00350770002804, all lot numbers; d. UDIDI 00350770002842, all lot numbers; e. UDIDI 00350770002859, all lot numbers; f. UDIDI 00350770002811, all lot numbers; g. UDIDI 00350770002866, all lot numbers; h. UDIDI 00350770002828, all lot numbers;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2035-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2035-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07
Z-2036-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07
Z-2037-2024	Class III	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07

Product code KYX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)