Early Bird Bleed Monitoring System Introducer fails to power on
Saranas, Inc. is recalling 953 units of the Early Bird Bleed Monitoring System Introducer Sheath Set due to a design error that prevents the device from powering on and completing self-tests. The product was distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with a design defect causing device malfunction (inability to power on and complete self-tests). No illnesses or injuries have been reported. As a medical device where functional failure could impact patient care, this qualifies as a risk-of-harm product, meeting the High severity criterion.
Plain-English summary
Saranas, Inc. is recalling 953 units of the Early Bird Bleed Monitoring System Introducer Sheath Set, REF FG001-01 (6F) and FG001-02 (8F). The devices were distributed nationwide, including in Pennsylvania, Michigan, Florida, West Virginia, Texas, New Jersey, Georgia, Louisiana, New York, Massachusetts, Connecticut, Arizona, Ohio, Tennessee, and Virginia.
The recall is due to a device design error that causes the device to fail to power on and complete its series of self-tests. This functional defect means the device may not function as intended during use.
Users who have received this product should refer to updated instructions for use that include a device check procedure to be performed before use to ensure the device is functioning appropriately. For more information about affected lot numbers or this recall, contact Saranas, Inc.
The recalled product
- Product
- Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
- Manufacturer
- Saranas, Inc.
- Affected units
- 953
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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
Distribution
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