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Recall Observatory FDA recall evidence

Device 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.

Z-0431-2013

July 26, 2012

Class II

Product summary

Firm
Stryker Orthobiologics, Inc.
Event
Event 62834
Status
Terminated
Classification
Class II
Quantity
3,268
Official record key
device-enforcement:Z-0431-2013

Official wording

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

Code information: Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.

Distribution pattern: Nationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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