Z-2037-2024 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2024
- Initiation Date
- March 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,102 cases (6,340,900 units)
Product Description
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO; d. 20mL Oral Syringe Orange NonSterile, Product Code BC-S20EO; e. 35mL Oral Syringe Orange NonSterile, Product Code BC-S35EO; f. 3mL Oral Syringe Orange NonSterile, Product Code BC-S3EO; g. 60mL Oral Syringe Orange NonSterile, Product Code BC-S60EO; h. 6mL Oral Syringe Orange NonSterile, Product Code BC-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 00350770002873, all lot numbers, SAP Numbers 120000488, 120001138; b. UDIDI 00350770002910, all lot numbers, SAP Numbers 120000492, 120001142; c. UDIDI 00350770002880, all lot numbers, SAP Numbers 120000489, 120001139; d. UDIDI 00350770002927, all lot numbers, SAP Numbers 120000493, 120001143; e. UDIDI 00350770002934, all lot numbers, SAP Numbers 120000494, 120001144; f. UDIDI 00350770002897, all lot numbers, SAP Numbers 120000490, 120001140; g. UDIDI 00350770002941, all lot numbers, SAP Numbers 120000495, 120001145; h. UDIDI 00350770002903, all lot numbers, SAP Numbers 120000491, 120001141