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

FDA device recall Z-0400-2024 · posted 2023-11-24 · Open, Classified

Recall details

Recalling firm

Becton Dickinson Infusion Therapy Systems Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

FOZ

Quantity affected

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.

Date initiated

2023-10-04

Date posted

2023-11-24

Location

Sandy, UT

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