Teleflex recalls D-Stat Flowable Hemostat (REF 4000) with expired diluent vials that may compromise sterility. Affected units have specific lot numbers and expiration dates. Consumers should check their product details.
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.
Teleflex is recalling D-Stat Flowable Hemostat (REF 4000) due to expired diluent vials that could lead to unsterile products. This poses a risk of infection or contamination during medical procedures if used improperly.
The diluent vial has expired and passed its shelf life, meaning it no longer meets sterility standards. Using this expired diluent could lead to contamination or infection during medical procedures if the product is not properly sterilized.
Medical professionals using the D-Stat Flowable Hemostat for sealing tissue oozing after procedures are most at risk. Patients receiving this product during surgery may also be affected if the diluent is expired.
Check for the product name 'D-Stat Flowable Hemostat', reference number REF 4000, and lot numbers 717535 (exp. 04/27/2023) or 717413 (exp. 04/25/2023).
Identify the lot number and expiration date on the product label to confirm if it matches the affected units.
The diluent vial has expired and passed its shelf life, which could compromise sterility and lead to infection risks during medical procedures.
Check the lot number and expiration date on the product label. If it matches the affected units (lot 717535 exp. 04/27/2023 or 717413 exp. 04/25/2023), contact Teleflex for further instructions.
The recall is for potential infection risks due to expired diluent, not direct injury. The hazard does not involve immediate risks like fire or laceration.
We’ve drafted a message you can send Teleflex to request your refund or repair — edit it as you like.
Subject: Recall Z-1611-2023 — Teleflex Teleflex Hello, I own a Teleflex that is covered by recall Z-1611-2023 from Teleflex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
