Z-2035-2024 Class III Ongoing
FDA device recall Z-2035-2024 was initiated by Avanos Medical, Inc. on Mar 4, 2024 and is designated Class III. Reason for recall: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. The recall status is ongoing. Affected quantity: 37,476 cases (16,704,600 units).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2024
- Initiation Date
- Mar 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,476 cases (16,704,600 units)
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
Code Information
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;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2035-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026