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U.S. Department of Health and Human Services

Class 2 Device Recall Superstat Modified Collagen Hemostatic Sponge

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 Class 2 Recall
Superstat Modified Collagen Hemostatic Sponge
see related information
Date Posted November 16, 2012
Recall Status1 Terminated on February 06, 2013
Recall Number Z-0338-2013
Recall Event ID 63581
Premarket Approval
PMA Number
P810040
Product Classification Agent, Absorbable Hemostatic, Collagen Based - Product Code LMF
Product Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. 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# SSG29, SSG47, SSG52, SSG54, SSG57, SSG60, SSG63, SSG65, SSG66.
Recalling Firm/
Manufacturer
Superstat Corp
2015 E University Dr
Rancho Dominguez, California 90220-6411
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LMF and Applicant = INTERFACE BIOMEDICAL LABORATORIES, INC.
PMAs with Product Code = LMF and Applicant = SUPERSTAT CORP.
PMAs with Product Code = LMF and Applicant = SUPERSTAT, INC.
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