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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Superstat Modified Collagen Hemostatic Sponge		see related information
Date Posted November 16, 2012
Recall Number Z-0335-2013
Product Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30. 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
Code Information Lot# R1018P, S1503P, S2802P, SSN03P .
Recalling Firm/
Manufacturer		 Superstat Corp
2015 E University Dr
Rancho Dominguez, California 90220-6411
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.
Action Superstat initially contacted customers by telephone and sent an Urgent - Device Recall Notification Letter on October 24, 2012, to all affected customers. The recall letter provided the reason for recall was due to inadequate documentation of quarterly dose sterility audits. The recall includes all lots and part numbers of Superstat produced between 2002 and 2012. Customers are instructed to complete and return the enclosed response form as soon as possible. Customers with questions are instructed to call customer service at (800) 487-3786. For questions regarding this recall call 310-605-1655.
Quantity in Commerce 26,422 units
Distribution 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.
 
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