According to the FDA the Surgical Care Group of Johnson & Johnson, Ethicon Inc, has issued a Class I Recallfor its two haemostatic products SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit. Haemostatic Matrix is a sterile, absorbable porcine gelatin paste intended for haemostatic use by applying to a bleeding surface. The gelatin paste is supplied in a pre-filled syringe to be mixed with 2 ml of additional liquid (sterile saline solution or thrombin).

The recall was initiated by the company after it was found that there was an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging. The potentially defective solutions were manufactured from September 16, 2011 through July 27, 2012. According to reports from the company these products were distributed from September 29, 2011 through August 7, 2012. The affected product may cause serious health consequences, including death.

SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is used in surgical procedures (other than ophthalmic) as an aide to stop the flow of bleeding (hemostasis) when controlling bleeding by use of a suture (ligature) or when other conventional methods are ineffective or impractical.

The product is a topical, absorbable hemostat consisting of a paste (flowable gelatin matrix) and a freeze-dried (lyophilized) Thrombin component. This above mentioned kit also contains components necessary for preparing and applying the matrix during surgery.

Some advantages of SURGIFLO™ Haemostatic Matrix:

  • The mixed product remains usable up to 8 hours
  • The product requires only 6 transfers when mixing matrix with sterile saline or thrombin solution.
  • The products are needle-free thrombin preparation
  • Two applicator tips are included with the product to improve access in surgical procedures:
    • Blue applicator tip: Flexible in all directions for precise placement in difficult-to-reach areas and cavities.
    • White applicator tip: Straight applicator tip that can be trimmed to desired length.

About Ethicon Inc

Ethicon Inc was founded 80 years back with the vision of research, and innovation in the field of pharmaceutics and pharmaceutical products with a commitment to improve the quality of patients’ lives. The first group of Ethicon scientists and researchers thought about healing in a new way – and in doing so, pioneered various sutures to enhance the work of surgeons and the lives of patients – recognized the opportunity for limitless innovation.