FDA Medical Device Recalls (openFDA)
Saranas, Inc.: Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
- Recall number
- Z-1684-2022
- Recalling firm
- Saranas, Inc.
- Product
- Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
- Status
- Open, Classified
- Initiated
- 2022-08-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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).
- Quantity
- 953
- 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, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QFJ
- Firm FEI
- 3016011241
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28