NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSt
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-2036-2024
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 Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 20mL Oral Syringe Blue NonSterile, Product Code BB-S20EO; e. 35mL Oral Syringe Blue NonSterile, Product Code BB-S35EO; f. 3mL Oral Syringe Blue NonSterile, Product Code BB-S3EO; g. 60mL Oral Syringe Blue NonSterile, Product Code BB-S60EO; h. 6mL Oral Syringe Blue NonSterile, Product Code BB-S6EO;
Lot/Code Info: a. UDIDI 00350770002958, all lot numbers, SAP Numbers 120000508, 120001160; b. UDIDI 00350770002996, all lot numbers, SAP Numbers 120000512, 120001164; c. UDIDI 00350770002965, all lot numbers, SAP Numbers 120000509, 120001161; d. UDIDI 00350770003009, all lot numbers, SAP Numbers 120000513, 120001165; e. UDIDI 00350770003016, all lot numbers, SAP Numbers 120000514, 120001166; f. UDIDI 00350770002972, all lot numbers, SAP Numbers 120000510, 120001162; g. UDIDI 00350770003023, all lot numbers, SAP Numbers120000515, 120001167; h. UDIDI 00350770002989, all lot numbers SAP Numbers 120000511, 120001163
Quantity Affected: 27,664 cases (12,155,300 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-2036-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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