PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: July 2, 2025 Initiated: May 21, 2025 #Z-2005-2025

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.

Details

Units Affected
50 units
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.
Location
Sandy, UT

Frequently Asked Questions

What product was recalled?
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly. Recalled by Becton Dickinson Infusion Therapy Systems, Inc.. Units affected: 50 units.
Why was this product recalled?
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 2, 2025. Severity: Moderate. Recall number: Z-2005-2025.