CLASS II Device recall · Reported 29 Nov 2017 · FDA Enforcement Report
Tissu-Trans Filtron recalled by Shippert Medical Technologies
Shippert Medical Technologies is recalling Tissu-Trans Filtron 1000. The recall was initiated on 20 Oct 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-0170-2018
- FDA event ID
- 78392
- Recalling firm
- Shippert Medical Technologies, Centennial, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Oct 2017
- FDA classified
- 22 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 20 Oct 2017 | Recall initiated by company | |
| 22 Nov 2017 | Classified by FDA | +33 days |
| 29 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential breach of sterility of the packaging.
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 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
Where it was distributed
Worldwide Distribution -- United States, Australia, and Netherlands.
Questions about this recall
Why was it recalled?
Potential breach of sterility of the packaging.
Which lots are affected?
Lot 12004
Where was it sold?
Worldwide Distribution -- United States, Australia, and Netherlands.
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.
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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