Recall Z-0331-2013 ยท LMF Agent, Absorbable Hemostatic, Collagen Based
Superstat Corp
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
| Date | Nov 16, 2012 (initiated Oct 24, 2012) |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.