BD Insyte Autoguard recallZ-0400-2024 · Becton Dickinson Infusion Therapy Systems Inc. · initiated Oct 4, 2023
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
Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 10/4/23, recall notices were emailed to customers and distributors who were asked to do the following: 1) Destroy all unused product subject to the recall following your institution's process for destruction. 2) For indwelling catheters, no further action is needed. 3) Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 4) Complete and return the customer response form via email to [email protected] Customers with recall questions, product complaints, or technical questions can call 1-844-823-5433, say recall when prompted, Mon-Fri 8:00am to 5:00PM CT, or email [email protected] In addition, distributors are asked to identify all customers within their distribution network that purchased affected product. Then distributors should provide a copy of the customer letter to these customers and advise them of the recall.
Recall details
- Recall number
- Z-0400-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 4, 2023
- Posted by the FDA
- Nov 24, 2023
- Recalling firm
- Becton Dickinson Infusion Therapy Systems Inc.
- Quantity
- 528,000
- Product code
- FOZ
- FDA submissions
- K201075
- Distribution
- US Nationwide distribution in the states of CA, NC, MI, WA, CO, FL, NJ, NM, IL, KY, TN, OH, TX, IN, LA, IA, MS, MO, NE, MD, NY, PA, GA, VA, ME, SC, RI, MA, PR.
Product description
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Code information (models, lots, serial numbers)
UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31
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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