REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Summary
The FDA issued a Class II for REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm by Becton Dickinson Infusion Therapy Systems, Inc.. Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract..
Details
Source
Device Recall
External ID
Z-2002-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
Product Description
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Lot/Code Info: Lot # 4290664/UDI:382903814336
Quantity Affected: 50 units
Reason for Recall
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-21
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 160 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-2002-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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