Reported Nov 28, 2012 · Terminated
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device…
Stryker Orthobiologics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Orthobiologics, Inc. · 45 Great Valley Pkwy · Malvern, PA · 19355-1302
Is this the product you have?
- Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
- Lot codes and dates
Part number 2113-0013lot numbers T1203002T1204005and T1206001
- Amount recalled
- 3,268
Where it was sold
Why it was recalled
When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T
This product could cause temporary or reversible health problems — stop using it.
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