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
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
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2017 | Recall initiated by company | |
| 22 Aug 2017 | Classified by FDA | +82 days |
| 30 Aug 2017 | Published 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 77518This product is part of a recall event; the main page for the event is Tissu-Trans Filtron 500, 3-Tt-filtron recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tissu-Trans Filtron 500, 3-Tt-filtron recalled | Shippert Medical Technologies | Sterility | Nationwide | |
| CLASS II | Tissu-Trans Filtron 250, 3-Tt-filtron recalled | Shippert Medical Technologies | Sterility | Nationwide | |
| CLASS II | Tissu-Trans Mega 1500, 3-Tt-mega recalled | Shippert Medical Technologies | Sterility | Nationwide | |
| CLASS II | Tissu-Trans Sfill 360, 3-Tt-sfill recalled | Shippert Medical Technologies | Sterility | Nationwide | |
| CLASS II | Tissu-Trans Filtron 100, 3-Tt-filtron recalled | Shippert Medical Technologies | Sterility | Nationwide | |
| CLASS II | Tissu-Trans Filtron 2000, 3-Tt-filtron recalled | Shippert Medical Technologies | Sterility | Nationwide |
More recalls from Shippert Medical Technologies
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tissu-Trans Filtron recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
| Device | CLASS II | Tissu-Trans Filtron recalled by Shippert Medical Technologies | Shippert Medical Technologies | Other | Nationwide |
| Device | CLASS II | Tissu-Trans MEGA recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
| Device | CLASS II | Tissu-Trans Filtron recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
| Device | CLASS II | Tissu-Trans Filtron recalled by Shippert Medical Technologies | Shippert Medical Technologies | Sterility | Nationwide |
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| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |