Recall Z-0400-2024— Becton Dickinson Infusion Therapy Systems Inc.

Name: FDA recall Z-0400-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-04

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson Infusion Therapy Systems Inc., initiated 2023-10-04. It names one FDA 510(k) clearance: K201075. Product: BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533. Reason: 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..

Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-04
Firm location: Sandy, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K201075 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV CatheterBecton, Dickinson and Company·cleared 2020-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.