FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1611-2023
·
Reported May 24, 2023
Enforcement
- Recall Number
- Z-1611-2023
- Event ID
- 92090
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- TELEFLEX LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 24, 2023
- Initiation Date
- April 12, 2023
- Classification Date
- May 18, 2023
- Address
- 3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States
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.
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 passed beyond the studied shelf life of the product.
Code Info
UDI/DI M20640000, Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023
Distribution
US Nationwide
Quantity
1140 units