REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
- Recall Initiated
- May 21, 2025
- Posted
- June 23, 2025
- Recall Number
- Z-2000-2025
- Quantity
- 50
- Firm Location
- Sandy, UT
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.
Lot / Code Info
Lot: 4222721/ UDI: 382903826339
Root Cause
Component design/selection
Action Taken
On May 21, 2025, Becton Dickinson Infusion Therapy (BD) issued a "Urgent: Medical Device Recall" Notification to affected consignees FedEx and E-Mail. BD asked consignees to take the following actions: 1. Immediately review your inventory for product listed in the above table. Cease use and destroy any unused affected devices. 2. For devices that have deployed and are currently in use or if an impacted device was previously used, no additional follow-up activities are required for patients that have completed therapy. 3. Share and post this Product Recall letter within your facility network and forward to any customers you may have distributed the product to ensure awareness. Ensure the contents of this Product Recall are read and understood by those within your organization. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.