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.
FDA Recall Z-0431-2013 · Posted 2012-11-22
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Recalling FirmStryker Orthobiologics, Inc.
Recall StatusTerminated
Product CodeLMF
Date Initiated2012-07-26
Date Terminated2014-10-29
Product Quantity3,268
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
Firm Action
Stryker sent a "MEDICAL DEVICE FIELD CORRECTION" dated July 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included a Business Reply Form for customers to complete and return via fax to 1-484-323-8803. Contact the firm at 1-888-774-8870 for questions regarding this notice.
Root Cause
Device Design
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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