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

Company: Saranas, Inc.
Recall Initiated: August 10, 2022
Recall Number: Z-1684-2022
Quantity: 953
Firm Location: Houston, TX

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.

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

Root Cause

Nonconforming Material/Component

Action Taken

On 8/10/22 correction notices were emailed to customers who were asked to do the following: 1. Review the updated Instructions for Use, specifically, "12 DIRECTIONS FOR USE" 2. Prior to the operation as part of device preparation, activate the device by pulling the battery isolation pull tab and observing that the green Power indicator is blinking, and no other lights remain on. Once confirmed, immediately press and hold the Power button to turn off the device. 3. During the power-on sequence, if there is an error, the device will sound an audible tone and the yellow error light will remain illuminated. The user should attempt to restart the device by pressing the Power button to turn off the device and turn the device back on for one additional attempt for use of the device. If the device does not power back on as intended (blinking green light only), the user must discontinue use of the device. If the device is defective, the user should obtain a new device, if available. The same safety check should be performed on the new device. The defective device should be returned to the recalling firm. 4. Complete and return the recall return response form Customers with additional questions are encouraged to contact the recalling firm at info@saranas.com or 1-833-ERLYBRD (833-375-9273).