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U.S. Department of Health and Human Services

Class 2 Device Recall BD Insyte" Autoguard" BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in

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  Class 2 Device Recall BD Insyte" Autoguard" BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in see related information
Date Initiated by Firm October 04, 2023
Date Posted November 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-0400-2024
Recall Event ID 93276
510(K)Number K201075  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Code Information UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31
Recalling Firm/
Manufacturer		 Becton Dickinson Infusion Therapy Systems Inc.
9450 S State St
Sandy UT 84070-3213
For Additional Information Contact
801-565-2300
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = Becton, Dickinson and Company
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