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U.S. Department of Health and Human Services

Class 2 Device Recall BD Insyte Autoguard BC Pro Winged Shielded IV Catheter

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 Class 2 Device Recall BD Insyte Autoguard BC Pro Winged Shielded IV Cathetersee related information
Date Initiated by FirmMay 21, 2025
Date PostedJune 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2004-2025
Recall Event ID 96865
510(K)NumberK201075 
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
ProductREF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Code Information Lot# 4208538/UDI: 00382903818112
Recalling Firm/
Manufacturer		 Becton Dickinson Infusion Therapy Systems, Inc.
9450 S State St
Sandy UT 84070-3213
For Additional Information ContactBD North American Regional Complaint Center
1844-823-5433
Manufacturer Reason
for Recall		Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
FDA Determined
Cause 2		Component design/selection
ActionOn 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.
Quantity in Commerce50 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FOZ
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