Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tr
Summary
The FDA issued a Class II for Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; by TELEFLEX LLC. Reason: The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has pass.
Details
Source
Device Recall
External ID
Z-1611-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
Lot/Code Info: UDI/DI M20640000, Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023
Quantity Affected: 1140 units
Reason for Recall
The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product.
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-12
Company
Morrisville, NC
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 147 device recalls issued in the same week, part of 413 device-related FDA actions this month.
TELEFLEX LLC has 139 FDA actions in our database, including 139 recalls.
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 (TELEFLEX LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TELEFLEX LLC have FDA actions?
TELEFLEX LLC has 139 FDA actions in our database, including 139 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1611-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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