BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatmen
Summary
The FDA issued a Class II for BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed f by Becton Dickinson & Company. Reason: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection..
Details
Source
Device Recall
External ID
Z-1244-2023
Action Date
2023-03-22
Status
Ongoing
Category
device
Product Description
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
Lot/Code Info: GTIN: N/A Lot Number: 2010670, Exp. Date:2031581 Lot Number: 2052365, Exp. Date:20270531
Quantity Affected: 1,472,400 units
Reason for Recall
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Distribution
Worldwide distribution - US Nationwide and the countries of Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Mexico, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-01
Company
Franklin Lakes, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Becton Dickinson & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson & Company have FDA actions?
Becton Dickinson & Company has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1244-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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