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Terminated

Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.

FDA Recall Z-3065-2017 · Posted None

Recalling FirmShippert Medical Technologies
Recall StatusTerminated
Product CodeN/A
Date Initiated2017-06-01
Date Terminated2024-01-30
Product Quantity5,188 units total

Reason for Recall

Seal integrity of the Tissu-Trans product sterile packages cannot be assured.

Firm Action

Customers were notified of the recall between 06/01/2017 and 06/14/2017 via FedEx letter. Instructions included remove and quarantine all affected devices, complete and return the response form, arrange for the return of affected devices, and notify any customers if further distributed.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV. and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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