Shippert Medical Technologies Recalls Tissu-Trans Filtron 1000 Due to Seal Integrity
Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 1000 because the seal integrity of the sterile packages cannot be assured.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in a medical device used for invasive procedures, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Shippert Medical Technologies is recalling 5,188 units of the Tissu-Trans Filtron 1000 (3-TT-FILTRON 1000). This medical device is intended for use in fat transfer and liposuction procedures. The recall is being conducted because the seal integrity of the product's sterile packages cannot be assured.
The affected units are identified by lot numbers 12047, 12077, and 61235. The products were distributed worldwide, including nationwide in the United States and in numerous international countries such as Italy, Germany, Japan, and the United Kingdom.
Consumers and healthcare providers should stop using the affected products immediately. The source text does not provide specific instructions for disposal or return, but users should contact the manufacturer or their medical device supplier for further guidance on how to handle the recalled items.
The recalled product
- Product
- Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.
- Manufacturer
- Shippert Medical Technologies
- Affected units
- 5,188
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 (3)
- Lot Numbers 12047
- 12077
- 61235.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Shippert Medical Technologies under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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Similar recalls
- ModerateShippert Medical Technologies Recalls Tissu-Trans Filtron 1000 Due to Sterility Breach
FDA (Devices) · 2017-11-29
- HighShippert Medical Technologies Recalls Tissu-Trans FILTRON 500 Due to Pouch Integrity Concerns
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