Z-0400-2024Class II

BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

Name: Z-0400-2024 BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Creator: Becton Dickinson Infusion Therapy Systems Inc.
Published: 2023-10-04
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2023-10-04 / Open, Classified / root cause: manufacturing process

FDA source

Becton Dickinson Infusion Therapy Systems Inc. began a recall of BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533 on 2023-10-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0400-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-04
Posted: 2023-11-24
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 528,000
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 codes and lots: UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0400-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0400-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-24

Product code FOZ

K201075Class IIBD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV CatheterBecton, Dickinson and Company / cleared 2020-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)