Recall Z-2458-2024 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson Infusion Therapy Systems, Inc.
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.
| Date | Jul 31, 2024 (initiated Jun 26, 2024) |
| Status | Open, Classified |
| Reason | Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process. |
| Root cause | Process control |
| Action | 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 furthe |
| Quantity | 26,400 units |
| Distribution | US: IL OUS: N/A0 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shield Becton, Dickinson and Company, Dec 18, 2020 |