—#199680

Product

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.

FDA product code: MGB — Device, Hemostasis, Vascular
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P990037
Affected lot / code info: UDI/DI M20640000, Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Teleflex 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.

Recalling firm

Firm: TELEFLEX LLC
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2023-04-12
Posted by FDA: 2023-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199680. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.