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HARVEST® AdiPrep®
TERUMO BCT, INC. · Model 51433 · UDI-DI 05020583514331
MUU
Prescription
10
510(k) clearances
363
Adverse events (2 deaths)
15
Recalls
41
Facilities
Description
ADI-25-03 Adipose Procedure Pack
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.