Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
Check against the official notice below — it lists the full affected range.
OriGen Biomedical, Inc. is recalling 169 units of its Reinforced Dual Lumen Cannula, model 23Fr. (REF: VV23F), sterile EO, which are used for venous drainage. The catheters have two identified deficiencies: some units lack barium sulfate, which is used to make the catheter visible on X-rays, and the actual catheter tip length is one centimeter shorter than what is printed on the tip.
The affected product was distributed worldwide, including throughout the United States and in multiple countries including Canada, Japan, Germany, India, Australia, and others. The recalled catheters are identified by UDI 00816203022103 and lot numbers N18431 and N18431-1. The source document does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Reason for recall: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip Distribution: Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Tha Quantity: 169 Lot/code info: UDI: 00816203022103, Lot: N18431, N18431-1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.