Recall Z-2037-2024 ยท KYX Dispenser, Liquid Medication
Avanos Medical, Inc.
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-S35E
| Date | Jun 7, 2024 (initiated Mar 4, 2024) |
| Status | Open, Classified |
| Reason | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 14,102 cases (6,340,900 units) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.