Saranas, Inc. Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Brand
Saranas, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Saranas, Inc. is recalling Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F) due to 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 up. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026