FDA Medical Device Recalls (openFDA)
Becton Dickinson Infusion Therapy Systems Inc.: BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
- Recall number
- Z-0400-2024
- 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
- Status
- Open, Classified
- Initiated
- 2023-10-04
- Posted
- 2023-11-24
- Terminated
- not on file
- Reason
- 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
- 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 BDRC48@bd.com 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 productcomplaints@bd.com 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
- 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.
- Lot, serial or model codes
- UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31
- 510(k) numbers
- K201075
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 1710034
- Firm city
- Sandy
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28