BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/h
Summary
The FDA issued a Class II for BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter by Becton Dickinson Infusion Therapy Systems Inc.. Reason: There is a breach in the product packaging that renders the product non-sterile..
Details
Source
Device Recall
External ID
Z-0306-2022
Action Date
2021-12-01
Status
Ongoing
Category
device
Product Description
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
Lot/Code Info: Catalog number/Model number: 383536; Batch numbers/UDI numbers: Lot: 1193055/(17)240630(10)1193055(30)80/(01)50382903835367, 2024-06-30; Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367, 2024-06-30 Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367, 2024-06-30 Lot: 1188953: (17)240630(10)1188953(30)80/(01)50382903835367, 2024-06-30
Quantity Affected: 155,840 devices, 80 units in each box
Reason for Recall
There is a breach in the product packaging that renders the product non-sterile.
Distribution
U.S. Nationwide Distribution: AR, AZ, MA, GA, NC, OH, WA, NY, NJ, HI, CA, MD, RI, MT, IN, PA, IL OK, OR, AK, CT, TX, ME, MO, FL, VA, LA, CO, UT O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-08
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton Dickinson Infusion Therapy Systems Inc. has 25 FDA actions in our database, including 15 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Becton Dickinson Infusion Therapy Systems Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton Dickinson Infusion Therapy Systems Inc. have FDA actions?
Becton Dickinson Infusion Therapy Systems Inc. has 25 FDA actions in our database, including 15 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0306-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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