Recall Z-2005-2025— Becton Dickinson Infusion Therapy Systems, Inc.

Name: FDA recall Z-2005-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-21

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson Infusion Therapy Systems, Inc., initiated 2025-05-21. It names one FDA 510(k) clearance: K201075. Product: REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly. Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract..

Recalling firm: Becton Dickinson Infusion Therapy Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-21
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

REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

Reason for recall

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

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