The Recall Desk
HighFDA (Devices)·Z-1330-2019·Announced 2019-05-22

Shippert Medical Technologies Recalls Tissu-Trans FILTRON 100 Due to Pouch Integrity Concerns

Shippert Medical Technologies is recalling Tissu-Trans FILTRON 100 sterile pouches because a cut or hole may compromise the product's sterility.

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 involves a risk-of-harm product (sterility breach) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Shippert Medical Technologies is recalling Tissu-Trans FILTRON 100, a sterile, disposable, one-patient use medical device. The recall is due to a potential defect where the product pouch may contain a cut or hole, which prevents assurance of the product's sterility without a visual examination.

A total of 6,553 units were distributed nationwide, including Puerto Rico, as well as to government and military entities. Foreign distribution included Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. The affected lot numbers are 61472, 61601, 61816, 61817, 61818, 61819, 61878, 61736, 61801, 61948, 62050, and 62139.

Healthcare providers and consumers should stop using the affected products and contact Shippert Medical Technologies for further instructions or a return.

The recalled product

Product
Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Manufacturer
Shippert Medical Technologies
Category
Medical Device — Surgical/Procedural
Hazard
Affected units
6,553

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 (12)

  • Lot numbers 61472
  • 61601
  • 61816
  • 61817
  • 61818
  • 61819
  • 61878
  • 61736
  • 61801
  • 61948
  • 62050
  • and 62139.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state 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 breach

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