FDA-Device2024-06-19Class III
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,
Hazard
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
Affected count
27,664 cases (12,155,300 units)
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2036-2024More Avanos Medical, Inc. recalls
- FDA-Device2026-06-17Avanos Medical MIC Safety PEG Kit 24 Fr recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos CORFLO Safety PEG Kit recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos CORFLO Safety PEG Kit with ENFit Connector recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos MIC Safety PEG Kit recalled for defective lidocaine injection
- FDA-Device2026-06-17Avanos Medical MIC Safety PEG Kit recalled for defective lidocaine injection
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