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U.S. Department of Health and Human Services

Class 3 Device Recall NEOMED Pharmacy Syringes

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  Class 3 Device Recall NEOMED Pharmacy Syringes see related information
Date Initiated by Firm March 04, 2024
Date Posted June 07, 2024
Recall Status1 Open3, Classified
Recall Number Z-2035-2024
Recall Event ID 94518
Product Classification Dispenser, liquid medication - Product Code KYX
Product 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;
Code Information a. UDIDI 00350770002798, all lot numbers; b. UDIDI 00350770002835, all lot numbers; c. UDIDI 00350770002804, all lot numbers; d. UDIDI 00350770002842, all lot numbers; e. UDIDI 00350770002859, all lot numbers; f. UDIDI 00350770002811, all lot numbers; g. UDIDI 00350770002866, all lot numbers; h. UDIDI 00350770002828, all lot numbers;
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact
470-448-5000
Manufacturer Reason
for Recall		 The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
FDA Determined
Cause 2		 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 provide notification to them, as well as report theirs and their customers inventory to Avanos via the acknowledgment form.
Quantity in Commerce 37,476 cases (16,704,600 units)
Distribution Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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