REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support pr
Check against the official notice below — it lists the full affected range.
OriGen Biomedical, Inc. is recalling the REF VV19F Reinforced Dual Lumen Cannula, 19Fr., a sterile, disposable medical catheter used as a single cannula. The recalled lot (N18394, Product Code VV19F, UDI 00816203022097) consists of 134 units that were distributed worldwide, including to multiple U.S. states and several countries including Canada, Belgium, Germany, Spain, Sweden, Thailand, and the United Kingdom.
The recall was issued because the clear extension tube on the catheter has the potential to separate from the hub, which could cause blood loss and may require medical intervention to prevent permanent injury or damage. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
Reason for recall: Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage Distribution: Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom Quantity: 134 Lot/code info: Product Code UDI Lot VV19F 00816203022097 N18394
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.