Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Summary
The FDA issued a Class II for Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG by Saranas, Inc.. 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 up.
Details
Source
Device Recall
External ID
Z-1684-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Lot/Code Info: 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
Quantity Affected: 953
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.
Distribution
US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-10
Company
Houston, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Saranas, Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Saranas, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Saranas, Inc. have FDA actions?
Saranas, Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1684-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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