CLASS II Device recall · Reported 30 Aug 2017 · FDA Enforcement Report

Tissu-Trans Filtron 1000, 3-Tt-filtron recalled

Shippert Medical Technologies is recalling Tissu-Trans Filtron 1000, 3-Tt-filtron 1000, distributed nationwide in the US. The recall was initiated on 1 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers 12047, 12077, 61235.
Quantity recalled5,188 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-3063-2017
FDA event ID
77518
Recalling firm
Shippert Medical Technologies, Centennial, CO
Classification
Class II
Status
Terminated
Recall initiated
1 Jun 2017
FDA classified
22 Aug 2017
Reported
30 Aug 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

1 Jun 2017Recall initiated by company
22 Aug 2017Classified by FDA+82 days
30 Aug 2017Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.

Where it was distributed

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.

Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyNevada

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Numbers 12047, 12077, 61235.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 77518

This product is part of a recall event; the main page for the event is Tissu-Trans Filtron 500, 3-Tt-filtron recalled.

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