Teleflex recall: Sterility Concern
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites…
Why was Teleflex 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI M20640000, Lot Numbers: 717535, exp. 04/27/2023; 717413, exp. 04/25/2023
- Product
- Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites…
- Recalling firm
- TELEFLEX LLC
- Quantity
- 1140 units
- Distribution
- US Nationwide
- Recall date
- May 24, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)