Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, 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 73 units of its Reinforced Dual Lumen Cannula, 32Fr. (model VV32F), sterile, ethylene oxide sterilized. The affected product has lot number P18806 and UDI 00816203022148. These catheters may have two deficiencies: the absence of barium sulfate, and an actual catheter tip length that is one centimeter shorter than stated on the printed tip marking.
The recalled catheters were distributed worldwide, including throughout the United States to at least 31 states and to numerous countries including Canada, Japan, Germany, and others. The source document does not specify any remedy or corrective action for consumers who may have obtained this product.
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: 73 Lot/code info: UDI: 00816203022148, Lot: P18806
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.