REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx On
Summary
The FDA issued a Class II for REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA by Becton Dickinson Infusion Therapy Systems Inc.. Reason: There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect fr.
Details
Source
Device Recall
External ID
Z-0025-2024
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Lot/Code Info: Lot # 2238464/ UDI-DI: (01)00382903868629
Quantity Affected: 98,000 units
Reason for Recall
There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.
Distribution
US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-29
Company
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 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson Infusion Therapy Systems Inc. has 25 FDA actions in our database, including 15 recalls and 10 clearances.
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 Infusion Therapy Systems Inc.) 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 Infusion Therapy Systems Inc. have FDA actions?
Becton Dickinson Infusion Therapy Systems Inc. has 25 FDA actions in our database, including 15 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0025-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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