Agent, Absorbable Hemostatic, Collagen Based

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

Potential for product to contain foreign matter, confirmed to be inspect fragments.

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

Some applicator tips from these lots had open seals.

Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes:

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes:

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

INSTAT - Agent, Absorbable Hemostatic, Collagen Based

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Helistat Absorbable Hemostatic,Collagen Based

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Helitene Absorbable Collagen Hemostatic Sponge

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Absorbable Collagen Sponge

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat.

When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T