BD Insyte Autoguard IV Catheter (BD) – Tubing Hole Risk (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Brand
Becton Dickinson Infusion Therapy Systems, Inc.
Lot Codes / Batch Numbers
Lot # 4127714/ UDI-DI: 00382903825332
Products Sold
Lot # 4127714/ UDI-DI: 00382903825332
Becton Dickinson Infusion Therapy Systems, Inc. is recalling BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.0 due to Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Recommended Action
Per FDA guidance
On June 26, 2024, Becton Dickinson Infusion Therapy Systems Inc. issued a "Urgent: Medical Device Product Recall" Notification to affected consignees via: mail. BD ask consignees to take the following actions: 1. Ensure the contents of this Product Recall communication are read and understood by those within your organization. 2. Immediately review your inventory for Catalog Number 382533, Lot number 4127714. Destroy all unused product subject to the recall following your institution s process for destruction. 3. If affected device was previously used on a patient without incident, no further action is necessary. If the device is currently in use and issue has not been observed, continue to use as normal. 4. Notify any and all entities of this recall to whom the affected product may have been transferred. 5. Complete the attached Customer Response Form and return to your distributor, whether or not you have any of the impacted material.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL
Page updated: Jan 10, 2026