Recall Z-0333-2013— Superstat Corp
Class II · Terminated
Class II FDA medical device recall by Superstat Corp, initiated 2012-10-24, terminated 2013-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. 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. Reason: 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..
- Recalling firm
- Superstat Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-24
- Terminated
- 2013-02-06
- Firm location
- Rancho Dominguez, CA, United States
Product description
Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30. 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.