Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, 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 435 units of its Reinforced Dual Lumen Cannula, 19Fr. (model VV19F), sterile, used for venous drainage. The cannulas were distributed worldwide, including throughout the United States and in countries such as Canada, Japan, Germany, India, and others. The recalled product may have two deficiencies: missing barium sulfate (which is used to make catheters visible on X-rays) and an actual catheter tip length that is one centimeter shorter than what is printed on the tip label.
The affected lot numbers are N18394, N18447, N18447-1, N18447-1A, P18909, and P18971. The source document 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.
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: 435 Lot/code info: UDI: 00816203022097, Lot: N18394, N18447, N18447-1, N18447-1A, P18909, P18971
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.