CLASS II ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report
Early Bird Bleed Monitoring System Introducer Sheath Set recalled
Saranas is recalling Early Bird Bleed Monitoring System Introducer Sheath Set, distributed nationwide in the US. The recall was initiated on 10 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1684-2022
- FDA event ID
- 90725
- Recalling firm
- Saranas, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Aug 2022
- FDA classified
- 7 Sep 2022
- Reported
- 14 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 10 Aug 2022 | Recall initiated by company | |
| 7 Sep 2022 | Classified by FDA | +28 days |
| 14 Sep 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Where it was distributed
US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.
Nationwide ArizonaConnecticutFloridaGeorgiaLouisianaMassachusettsMichiganNew JerseyNew YorkOhioPennsylvaniaTennesseeTexasVirginiaWest Virginia
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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