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Liposat Pro plus

Möller Medical GmbH · Model 00003974 · UDI-DI 04260632792308

MUU

510(k) clearances

363

Adverse events (2 deaths)

Recalls

Facilities

Description

The "Liposat Pro plus" is a pump that is used in the field of aesthetic body contouring. The "Liposat Pro plus" is used to promote aqueous solutions for the production of tumescence local anesthesia as well as body-own, subcutaneous tissue and its components in the body. The pump "Liposat Pro plus" may only be used with the tube set "TLA Tubing Liposat Pro plus" and "Fat Tubing Liposat Pro plus" of the the Möller Medical GmbH.

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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Data 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.