NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonS
Summary
The FDA issued a Class III for NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptio by Avanos Medical, Inc.. Reason: The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers..
Details
Source
Device Recall
External ID
Z-2037-2024
Action Date
2024-06-19
Status
Ongoing
Category
device
Product Description
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-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
Lot/Code Info: 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
Quantity Affected: 14,102 cases (6,340,900 units)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-04
Company
Alpharetta, GA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Avanos Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Avanos Medical, Inc. have FDA actions?
Avanos Medical, Inc. has 55 FDA actions in our database, including 51 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2037-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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