Saranas, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1684-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

Product Classification:

Class II

Date Initiated: August 10, 2022

Date Posted: September 14, 2022

Recall Number: Z-1684-2022

Event ID: 90725

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.

Status: Ongoing

Product Quantity: 953

Code Information:

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

Distribution Pattern:

US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.

Voluntary or Mandated:

Voluntary: Firm initiated