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U.S. Department of Health and Human Services

Class 2 Device Recall Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat

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 Class 2 Recall
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat
see related information
Date Posted November 22, 2012
Recall Status1 Open
Recall Number Z-0431-2013
Recall Event ID 62834
Premarket Approval
PMA Number
P050044
Product Classification Agent, Absorbable Hemostatic, Collagen Based - Product Code LMF
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.
Code Information Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.
Recalling Firm/
Manufacturer
Stryker Orthobiologics, Inc.
45 Great Valley Pkwy
Malvern, Pennsylvania 19355-1302
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 3,268
Distribution 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LMF and Applicant = ORTHOVITA, INC.
PMAs with Product Code = LMF and Applicant = STRYKER CORP.
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