Z-2458-2024Class II

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

Name: Z-2458-2024 BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in...
Creator: Becton Dickinson Infusion Therapy Systems, Inc.
Published: 2024-06-26
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2024-06-26 / 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, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC... on 2024-06-26. FDA classified it as Class II and gives the reason as "Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process". 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-2458-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-26
Posted: 2024-07-31
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: 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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 26,400 units
Distribution: US: IL OUS: N/A0
Product codes and lots: Lot # 4127714/ UDI-DI: 00382903825332

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2458-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2458-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-07	2024-07-31

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)