Z-2036-2024 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
- 27,664 cases (12,155,300 units)
Product Description
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile, Product Code BB-S60EO; h. 6mL Oral Syringe Blue NonSterile, Product Code BB-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 00350770002958, all lot numbers, SAP Numbers 120000508, 120001160; b. UDIDI 00350770002996, all lot numbers, SAP Numbers 120000512, 120001164; c. UDIDI 00350770002965, all lot numbers, SAP Numbers 120000509, 120001161; d. UDIDI 00350770003009, all lot numbers, SAP Numbers 120000513, 120001165; e. UDIDI 00350770003016, all lot numbers, SAP Numbers 120000514, 120001166; f. UDIDI 00350770002972, all lot numbers, SAP Numbers 120000510, 120001162; g. UDIDI 00350770003023, all lot numbers, SAP Numbers120000515, 120001167; h. UDIDI 00350770002989, all lot numbers SAP Numbers 120000511, 120001163