Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0431-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2012-07-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0431-2013
Date of alert
2012-07-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Orthobiologics, Inc.
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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