BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63
FDA device recall Z-2458-2024 · posted 2024-07-31 · Open, Classified
Recall details
- Recalling firm
- Becton Dickinson Infusion Therapy Systems, Inc.
- Reason for recall
- Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FOZ
- Quantity affected
- 26,400 units
- Distribution
- US: IL OUS: N/A0
- Date initiated
- 2024-06-26
- Date posted
- 2024-07-31
- Location
- Sandy, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter (K201075) | Becton, Dickinson and Company | 2020-12-18 |