The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3064-2017·Announced 2017-08-30

FDA Recalls Tissu-Trans Filtron 2000 Due to Sterile Seal Integrity Concerns

Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 2000 because the sterile package seal integrity 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 risk of harm (contamination due to seal failure) for a medical device where no specific injuries or illnesses are reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Tissu-Trans Filtron 2000, manufactured by Shippert Medical Technologies. The product is intended for use in fat transfer and liposuction procedures. The recall involves 5,188 units distributed worldwide, including nationwide distribution in the United States and in multiple international countries.

The reason for the recall is that the seal integrity of the sterile packages cannot be assured. This defect poses a risk of contamination to the medical device. The affected lot numbers are 11947, 12003, 12078, and 12110.

Healthcare providers and consumers who have these specific units should stop using them immediately. Shippert Medical Technologies is the firm responsible for the recall and is managing the distribution of the affected products.

The recalled product

Product
Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.
Manufacturer
Shippert Medical Technologies
Category
Medical Device — Surgical / Plastic Surgery
Hazard
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 (4)

  • Lot Numbers 11947
  • 12003
  • 12078
  • 12110.

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

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 →

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