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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

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.
Recall Number Z-0431-2013
Classification Class II
Code Info Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.
Product Distributed Qty 3,268
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. This small amount of blood (approximately 0.2 mL) would then migrate to the bottom of the centrifuge cup after the 2 minute centrifuge spin cycle.

Event Detail

Event Id 62834
Product Type Devices
Status Ongoing
Recalling Firm Stryker Orthobiologics, Inc.
City Malvern
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-26
Initial Firm Notification of Consignee or Public Letter
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