Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Check against the official notice below — it lists the full affected range.
Saranas, Inc. is recalling 953 units of its Early Bird Bleed Monitoring System Introducer Sheath Set due to a device design error that prevents the device from powering on and completing its self-tests. The affected products include two models (6F and 8F versions) that were distributed nationwide across multiple states including Pennsylvania, Michigan, Florida, West Virginia, Texas, New Jersey, Georgia, Louisiana, New York, Massachusetts, Connecticut, Arizona, Ohio, Tennessee, and Virginia. Specific lot numbers and UDI codes for the recalled devices are provided in the recall notice.
In response to this issue, the manufacturer is updating the instructions for use to include a device check procedure that users should perform before operation to ensure the device is functioning appropriately. The source document does not specify a remedy or next steps for consumers who have already purchased or received affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
Reason for recall: Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately. Distribution: US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA. Quantity: 953 Lot/code info: UDI/REF/Lot: 00866532000402/FG001-01/510090S, 511110A, 510120F, 102422, 102445, 102531, 102671, 102685, 102731; 00866532000419/FG001-02/515070A, 528090C, 510120G, 511110B, 102567, 102610, 102611
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.