Superstat Corp: Medical Device Recall in 2012 - (Recall #: Z-0339-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

Product Classification:

Class II

Date Initiated: October 24, 2012

Date Posted: November 28, 2012

Recall Number: Z-0339-2013

Event ID: 63581

Reason for Recall:

The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.

Status: Terminated

Product Quantity: 26,422 units

Code Information:

Lot# SSK02D, SSK05D.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated