The Recall Desk
HighFDA (Devices)·Z-3061-2017·Announced 2017-08-30

Shippert Medical Technologies Recalls Tissu-Trans Filtron 250 Due to Seal Integrity

Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 250 because the seal integrity of the sterile packages cannot be assured.

What this means for you

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. The hazard involves a potential loss of sterility in a medical device used for invasive procedures, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Shippert Medical Technologies is recalling 5,188 units of the Tissu-Trans Filtron 250 (3-TT-FILTRON 250) medical device. The product is intended for use in fat transfer and liposuction procedures. The recall is being conducted because the seal integrity of the sterile packages cannot be assured.

The affected units are identified by Lot Numbers 12005, 12019, 12044, 61286, and 61421. 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 recall is classified as Class II by the U.S. Food and Drug Administration.

The recalled product

Product
Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.
Manufacturer
Shippert Medical Technologies
Category
Medical Device — Surgical / Fat Transfer
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 (5)

  • Lot Numbers 12005
  • 12019
  • 12044
  • 61286
  • 61421.

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 →

Related recalls

Same manufacturer · Shippert Medical Technologies

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Same hazard · sterility compromise

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