Recall Z-0400-2024 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson Infusion Therapy Systems Inc.
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
| Date | Nov 24, 2023 (initiated Oct 4, 2023) |
| Status | Open, Classified |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shield Becton, Dickinson and Company, Dec 18, 2020 |