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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 Syringessee related information
Date Initiated by FirmMarch 04, 2024
Date PostedJune 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2037-2024
Recall Event ID 94518
Product Classification Dispenser, liquid medication - Product Code KYX
ProductNEOMED* 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-S35EO; f. 3mL Oral Syringe Orange NonSterile, Product Code BC-S3EO; g. 60mL Oral Syringe Orange NonSterile, Product Code BC-S60EO; h. 6mL Oral Syringe Orange NonSterile, Product Code BC-S6EO
Code Information a. UDIDI 00350770002873, all lot numbers, SAP Numbers 120000488, 120001138; b. UDIDI 00350770002910, all lot numbers, SAP Numbers 120000492, 120001142; c. UDIDI 00350770002880, all lot numbers, SAP Numbers 120000489, 120001139; d. UDIDI 00350770002927, all lot numbers, SAP Numbers 120000493, 120001143; e. UDIDI 00350770002934, all lot numbers, SAP Numbers 120000494, 120001144; f. UDIDI 00350770002897, all lot numbers, SAP Numbers 120000490, 120001140; g. UDIDI 00350770002941, all lot numbers, SAP Numbers 120000495, 120001145; h. UDIDI 00350770002903, all lot numbers, SAP Numbers 120000491, 120001141
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
ActionAvanos 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 Commerce14,102 cases (6,340,900 units)
DistributionWorldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Switzerland, Netherlands, Singapore.
Total Product Life CycleTPLC 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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