Recall Z-0170-2018— Shippert Medical Technologies

Name: FDA recall Z-0170-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-20

Class II · Terminated

Class II FDA medical device recall by Shippert Medical Technologies, initiated 2017-10-20, terminated 2018-10-09. It names one FDA 510(k) clearance: K092482. Product: Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.. Reason: Potential breach of sterility of the packaging..

Recalling firm: Shippert Medical Technologies
Classification: Class II
Status: Terminated
Initiated: 2017-10-20
Terminated: 2018-10-09
Firm location: Centennial, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K092482 — TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500Shippert Medical Technologies Corp.·cleared 2009-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.

Reason for recall

Potential breach of sterility of the packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.