Recall Z-0431-2013— Stryker Orthobiologics, Inc.
Class II · Terminated
Class II FDA medical device recall by Stryker Orthobiologics, Inc., initiated 2012-07-26, terminated 2014-10-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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.
- Recalling firm
- Stryker Orthobiologics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-26
- Terminated
- 2014-10-29
- Firm location
- Malvern, PA, United States
Product description
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.
Reason for recall
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
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