Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, 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 its Reinforced Dual Lumen Cannula, 16Fr. (model VV16F), a sterile device used for venous drainage. The recalled catheters may have two deficiencies: they may be missing barium sulfate, which is used to make catheters visible on X-rays, and the actual catheter tip length may be one centimeter shorter than what is printed on the tip. A total of 452 units have been distributed worldwide, including across 31 U.S. states and multiple countries such as Canada, Japan, Germany, and others.
The affected lots are N18404, N18446, N18640, N18640-1, and R19208, identifiable by UDI 00816203022073. 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: 452 Lot/code info: UDI 00816203022073, Lot: N18404, N18446, N18640, N18640-1, R19208
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.