Shippert Medical Technologies Recalls Tissu-Trans Filtron 1000 Due to Sterility Breach
Shippert Medical Technologies is recalling 56 units of the Tissu-Trans Filtron 1000 device due to a potential breach of packaging sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a 'potential' breach of sterility without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Shippert Medical Technologies is recalling 56 units of the Tissu-Trans Filtron 1000, Catalog Number 3-TT-FILTRON 1000. This medical device is used for fat transfer and liposuction procedures. The recall is being conducted because of a potential breach of sterility in the packaging.
The affected units are from Lot 12004. The products were distributed worldwide, specifically in the United States, Australia, and the Netherlands. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients who have used or possess this specific lot of the Tissu-Trans Filtron 1000 should stop using the device and contact Shippert Medical Technologies for further instructions on how to proceed.
The recalled product
- Product
- Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
- Manufacturer
- Shippert Medical Technologies
- Hazard
- Affected units
- 56
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 12004
Distribution
Distribution scope not specified by the agency.
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