FDA Device recall Z-0431-2013
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat by Stryker Orthobiologics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0431-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-26 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Orthobiologics |
| Distribution | US |
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.
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
Identifiers
| code_info | Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0431-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.