Z-0331-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- October 24, 2012
- Termination Date
- February 6, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,422 units
Product Description
Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. 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
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.
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.
Code Information
Lot#P0616P, SSK15P