Superstat Corp: 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.

Agency Publication Date: November 16, 2012

Affected Products

Product: 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

Lot#P0616P, SSK15P

Lot Numbers:

P0616P

Product: Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. 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

Lot#R0117D, SSK03D.

Lot Numbers:

R0117D

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

Lot#R0315P, R0316P, R0317P, R1026P, S0703P, S1503P, SSK01P, SSM01P, SSN01P, SSN08P, SSN10P, SSN11P.

Lot Numbers:

R0315P

Product: Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. 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

Lot# R1018D, SSM02D, SSN12D .

Lot Numbers:

R1018D

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

Lot# R1018P, S1503P, S2802P, SSN03P .

Lot Numbers:

R1018P

Product: Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. 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

Lot# SSC02, SSF02 .

Lot Numbers:

SSC02

Product: Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. 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

Lot# SSF02, SSF03.

Lot Numbers:

SSF02

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

Lot# SSG29, SSG47, SSG52, SSG54, SSG57, SSG60, SSG63, SSG65, SSG66.

Lot Numbers:

SSG29

Product: 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

Lot# SSK02D, SSK05D.

Lot Numbers:

SSK02D

Product: Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. 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

Lot# SSK07P.

Lot Numbers:

SSK07P

Product: Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30. 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

Lot# SSL01C, SSN04C.

Lot Numbers:

SSL01C

Product: Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. 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

Lot# SSN02D.

Lot Numbers:

SSN02D

Lot# SSN12D.

Lot Numbers:

SSN12D

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63581

Status: Resolved

Manufacturer: Superstat Corp

Manufactured In: United States

Units Affected: 13 products (26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units; 26,422 units total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot#P0616P, SSK15P

Lot Numbers:

P0616P

Lot#R0117D, SSK03D.

Lot Numbers:

R0117D

Lot#R0315P, R0316P, R0317P, R1026P, S0703P, S1503P, SSK01P, SSM01P, SSN01P, SSN08P, SSN10P, SSN11P.

Lot Numbers:

R0315P

Lot# R1018D, SSM02D, SSN12D .

Lot Numbers:

R1018D

Lot# R1018P, S1503P, S2802P, SSN03P .

Lot Numbers:

R1018P

Lot# SSC02, SSF02 .

Lot Numbers:

SSC02

Lot# SSF02, SSF03.

Lot Numbers:

SSF02

Lot# SSG29, SSG47, SSG52, SSG54, SSG57, SSG60, SSG63, SSG65, SSG66.

Lot Numbers:

SSG29

Lot# SSK02D, SSK05D.

Lot Numbers:

SSK02D

Lot# SSK07P.

Lot Numbers:

SSK07P

Lot# SSL01C, SSN04C.

Lot Numbers:

SSL01C

Lot# SSN02D.

Lot Numbers:

SSN02D

Lot# SSN12D.

Lot Numbers:

SSN12D

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 63581

Status: Resolved

Manufacturer: Superstat Corp

Manufactured In: United States