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;
This recall is currently active, issued June 7, 2024. It was issued by Avanos Medical, Inc..
- Company
- Avanos Medical, Inc.
- Recall Initiated
- March 4, 2024
- Posted
- June 7, 2024
- Recall Number
- Z-2036-2024
- Quantity
- 27,664 cases (12,155,300 units)
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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 fieldactioncare@avanos.com. 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.