BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Summary
The FDA issued a Class II for BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X by Becton Dickinson Infusion Therapy Systems Inc.. Reason: Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick.
Details
Source
Device Recall
External ID
Z-0400-2024
Action Date
2023-12-06
Status
Ongoing
Category
device
Product Description
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Lot/Code Info: UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31
Quantity Affected: 528,000
Reason for Recall
Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
Distribution
US Nationwide distribution in the states of CA, NC, MI, WA, CO, FL, NJ, NM, IL, KY, TN, OH, TX, IN, LA, IA, MS, MO, NE, MD, NY, PA, GA, VA, ME, SC, RI, MA, PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-04
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 190 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-0400-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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