Becton Dickinson Infusion Therapy Systems Inc.: 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

Is my product affected?

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-th

• UPC 50382903835367

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson is recalling 155,840 BD Nexiva closed IV catheter systems (20 GA 1.00 IN, model 383536) due to packaging breaches that render the products non-sterile. The affected devices were distributed nationwide across multiple states including Arkansas, Arizona, Massachusetts, Georgia, North Carolina, Ohio, Washington, New York, New Jersey, Hawaii, California, Maryland, Rhode Island, Montana, Indiana, Pennsylvania, Illinois, Oklahoma, Oregon, Alaska, Connecticut, Texas, Maine, Missouri, Florida, Virginia, Louisiana, Colorado, and Utah. Four specific lot numbers are affected: 1193055, 1166273, 1166273, and 1188953, all with an expiration date of June 30, 2024.

Non-sterile IV catheters pose a risk of infection if used. The recall notice does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a breach in the product packaging that renders the product non-sterile.

Details from the source

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 Quantity: 155,840 devices, 80 units in each box 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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