Home › Bimini Technologies LLC › AutoPose Restore
AutoPose Restore
Bimini Technologies LLC · Model ABS-101035-1 · UDI-DI 00850034511276
MUU
Prescription
10
510(k) clearances
363
Adverse events (2 deaths)
15
Recalls
41
Facilities
Description
A sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous adipose tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 micron filter for screening the tissue particle size to allow for easier injection through small, 18-21G injectors.
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 | 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 | |
| 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.