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Puregraft 850 System
Bimini Technologies LLC · Model 850/PURE · UDI-DI 00850034511191
MUU
Prescription
1
510(k) clearances
363
Adverse events (2 deaths)
15
Recalls
41
Facilities
Description
A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filtering, and transferring autologous fat tissue for reinjecting back into the same patient.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-02 | Shippert Medical Technologies | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. |
| 2018-02-02 | Shippert Medical Technologies | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. |
| 2018-02-02 | Shippert Medical Technologies | |
| 2018-02-02 | Shippert Medical Technologies | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. |
| 2018-02-02 | Shippert Medical Technologies | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. |
| 2018-02-02 | Shippert Medical Technologies | The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. |
| 2018-02-02 | Shippert Medical Technologies | |
| 2017-10-20 | Shippert Medical Technologies | Potential breach of sterility of the packaging. |
| 2017-08-08 | LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC | Presence of bacterial endotoxins levels above the acceptable limit |
| 2016-11-03 | Terumo BCT, Inc. | Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operat |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.