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U.S. Department of Health and Human Services

Class 2 Device Recall Early Bird Bleed Monitoring System

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 Class 2 Device Recall Early Bird Bleed Monitoring Systemsee related information
Date Initiated by FirmAugust 10, 2022
Create DateSeptember 07, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1684-2022
Recall Event ID 90725
Product Classification Intravascular bleed monitor - Product Code QFJ
ProductEarly Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
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
FEI Number 3016011241
Recalling Firm/
Manufacturer		 Saranas, Inc.
2450 Holcombe Blvd Ste X
Houston TX 77021-2039
For Additional Information ContactOdell Roberts
833-375-9273
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 in Commerce953
DistributionUS Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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