Early Bird Bleed Monitoring System Introducer Sheath Set… recallZ-1684-2022 · Saranas, Inc. · initiated Aug 10, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Saranas, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] or 1-833-ERLYBRD (833-375-9273).
Recall details
- Recall number
- Z-1684-2022
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2022
- Recalling firm
- Saranas, Inc.
- Quantity
- 953
- Product code
- QFJ
- Distribution
- US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.
Product description
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Code information (models, lots, serial 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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Early Bird Bleed Monitoring System FG001-01Saranas Inc. · Intravascular Bleed Monitor1 recall1 death2 reports
- Early Bird Bleed Monitoring System FG001-02Saranas Inc. · Intravascular Bleed Monitor1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page