Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, 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
Check against the official notice below — it lists the full affected range.
OriGen Biomedical, Inc. is recalling 1,517 units of Reinforced Dual Lumen Cannulas (13Fr., REF: VV13F, Sterile EO) used in medical procedures. The recalled catheters may have two deficiencies: missing barium sulfate and an actual catheter tip length that is one centimeter shorter than what is printed on the tip. The affected lots include N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, and N18573.
The recalled products were distributed worldwide, including throughout the United States and to multiple countries including Canada, Japan, Australia, and European nations. The source does not specify a remedy 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: 1517 Lot/code info: UDI: 00816203022059, Lot: N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, N18573
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.