FDAFebruary 26, 2015device
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.
What to do
FDA enforcement status: Terminated
Brands named
orthovita inc dba stryker orthobiologicsorthovitaorthovita inc
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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