Z-0431-2013 Class II Terminated
FDA device recall Z-0431-2013 was initiated by Stryker Orthobiologics, Inc. on July 26, 2012 and is designated Class II. 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 b… The recall status is terminated (terminated October 29, 2014). Affected quantity: 3,268.
Recall Details
- Product Type
- Devices
- Report Date
- November 28, 2012
- Initiation Date
- July 26, 2012
- Termination Date
- October 29, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,268
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
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
Code Information
Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.