Z-0331-2013Class II

Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when...

Name: Z-0331-2013 Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when...
Creator: Superstat Corp
Published: 2012-10-24
License: https://open.fda.gov/license/

Superstat Corp. / initiated 2012-10-24 / Terminated / root cause: manufacturing process

FDA source

Superstat Corp began a recall of Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely... on 2012-10-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0331-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-24
Posted: 2012-11-16
Terminated: 2013-02-06
Recalling firm: Superstat Corp.
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
Product code: LMF Agent, Absorbable Hemostatic, Collagen Based
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot#P0616P, SSK15P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0331-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0331-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0332-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0333-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0334-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0335-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0336-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0337-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0338-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0339-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0340-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0341-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0342-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16
Z-0343-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-16

Product code LMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)