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U.S. Department of Health and Human Services

Class 2 Device Recall TELEFLEX DStat Flowable Hemostat

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 Class 2 Device Recall TELEFLEX DStat Flowable Hemostatsee related information
Date Initiated by FirmApril 12, 2023
Date PostedMay 18, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1611-2023
Recall Event ID 92090
PMA NumberP990037 
Product Classification Device, hemostasis, vascular - Product Code MGB
ProductTeleflex (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.
Code Information UDI/DI M20640000, Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023
FEI Number 3005747797
Recalling Firm/
Manufacturer		 TELEFLEX LLC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionTeleflex issued an URGENT - MEDICAL DEVICE RECALL notice to its consignees on 04/12/2023 via FedEx 2nd day. The notice explained the issue and the hazard and requested the following actions be taken: Medical Facilities - immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. If impacted product is on hand, mark the applicable checkbox on the Acknowledgement Form and fax it to 1-855-419-8507, including Attn: Customer Service or using the email address recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Distributors were directed to immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. They were further directed to notify their customers, collect the response forms, and upon completion of the action forward the completed Acknowledgement Form to recalls@teleflex.com.
Quantity in Commerce1140 units
DistributionUS Nationwide
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.
PMA DatabasePMAs with Product Code = MGB
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