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Open, Classified

NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d. 20mL Oral Syringe Amber NonSterile, Product Code BA-S20EO; e. 35mL Oral Syringe Amber NonSterile, Product Code BA-S35EO; f. 3mL Oral Syringe Amber NonSterile, Product Code BA-S3EO; g. 60mL Oral Syringe Amber NonSterile, Product Code BA-S60EO; h. 6mL Oral Syringe Amber NonSterile, Product Code BA-S6EO;

FDA Recall Z-2035-2024 · Posted 2024-06-07

Recalling FirmAvanos Medical, Inc.
Recall StatusOpen, Classified
Product CodeKYX
Date Initiated2024-03-04
Product Quantity37,476 cases (16,704,600 units)

Reason for Recall

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

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 [email protected]. 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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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