Teleflex D-Stat Flowable Hemostat Recalled for Expired Diluent Vial
Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall with no reported illnesses or injuries. The expired diluent creates a theoretical loss of sterility assurance, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex LLC is recalling 1140 units of D-Stat Flowable Hemostat (REF 4000) distributed nationwide in the United States. The affected lot numbers are 717535 and 717413. The device is intended for sealing residual oozing of tissue tracts at femoral access sites previously closed by suture or collagen-based hemostatic devices.
The recalled product contains an expired diluent vial. The diluent component has passed beyond its studied shelf life, meaning the sterility of this component cannot be assured. If the product is used, the sterility assurance of the diluent is compromised.
The recalled product
- 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.
- Manufacturer
- TELEFLEX LLC
- Hazard
- Affected units
- 1,140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI M20640000
- Lot Numbers: 717535
- exp. 04/27/2023
- 717413
- exp. 04/25/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · TELEFLEX LLC
See all →- HighPilling Wecksorb Neurosponges Surgical Sponges Recalled for Endotoxin Contamination
FDA (Devices) · 2026-07-08
- HighTeleflex Pilling Surgical Retractor Recalled for Incomplete Cleaning Instructions
FDA (Devices) · 2023-07-12
- ModerateTeleflex Surgical Retractor Recalled for Incomplete Pre-Cleaning Instructions
FDA (Devices) · 2023-07-12
- ModerateTeleflex Pilling O'Reilly Esophageal Retractor Recalled for Incomplete Cleaning Instructions
FDA (Devices) · 2023-07-12
- SevereEndotracheal Tubes Recalled for Potential 15mm Connector Disconnection
FDA (Devices) · 2023-07-05
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighTeleflex Visistat Skin Staplers Recalled for Sterility Deficiency
FDA (Devices) · 2016-12-21
- HighTeleflex Recalls Electrosurgical Coagulation Suction Tubes Due to Sterility Concerns
FDA (Devices) · 2014-01-22
- HighTeleflex Recalls Electrosurgical Suction Tubes Due to Sterility Concerns
FDA (Devices) · 2014-01-22
- HighTeleflex Recalls Sengstaken Tubes Due to Sterility Concerns
FDA (Devices) · 2014-04-30
- ModerateTeleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Compromise
FDA (Devices) · 2020-08-12
- HighTeleflex Breathing Tubes Recalled Due to Reports of Tearing
FDA (Devices) · 2022-06-01