BD Insyte Autoguard recallZ-2458-2024 · Becton Dickinson Infusion Therapy Systems, Inc. · initiated Jun 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson Infusion Therapy Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2458-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2024
- Posted by the FDA
- Jul 31, 2024
- Recalling firm
- Becton Dickinson Infusion Therapy Systems, Inc.
- Quantity
- 26,400 units
- Product code
- FOZ
- FDA submissions
- K201075
- Distribution
- US: IL OUS: N/A0
Product 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.
Code information (models, lots, serial numbers)
Lot # 4127714/ UDI-DI: 00382903825332
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
Product lines
Other devices under the same FDA submission
53 devices cleared under K201075 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Insyte Autoguard Shielded IV Catheter 381834Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days388 reports
- BD Insyte Autoguard 381433Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall314 reports
- BD Insyte Autoguard 382534Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days359 reports
- BD Insyte Autoguard 381434Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall303 reports
- BD Insyte Autoguard Shielded IV Catheter 381812Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days304 reports
- BD Insyte Autoguard 381412Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days294 reports
- BD Insyte Autoguard 382633Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall126 reports
- BD Insyte-N Autoguard 381411Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days154 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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