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.
Recall
- Recall Number
- Z-2458-2024
- Event Number
- 94896
- Firm
- Becton Dickinson Infusion Therapy Systems, Inc.
- FEI Number
- 1710034
- Product Code
- FOZ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- June 26, 2024
- Posted
- July 31, 2024
- Address
- 9450 S State St, Sandy, UT, 84070-3213
Description
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.
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
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.
US: IL OUS: N/A0
26,400 units