FDA-Device2015-04-08Class II
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.
Orthovita, Inc., dBA Stryker Orthobiologics.
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.
Sold states
Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
Affected count
274
Manufactured in
45 Great Valley Pkwy, N/A, Malvern, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1353-2015Don't want to check this manually?
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