The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1331-2019·Announced 2019-05-22

Shippert Medical Technologies Recalls Tissu-Trans FILTRON 250 Due to Pouch Integrity Concerns

Shippert Medical Technologies is recalling Tissu-Trans FILTRON 250 sterile filters because the pouch integrity cannot be assured without visual examination.

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

Plain-English summary

Shippert Medical Technologies is recalling Tissu-Trans FILTRON 250 sterile, disposable, one-patient use filters. The recall involves 6,553 units distributed nationwide, including Puerto Rico, as well as to government/military entities and foreign countries including 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 61507, 61578, 61682, 61689, 61849, 61879, 62011, 62088, and 62108.

The recall was initiated because the pouch integrity of the sterile product cannot be assured without a visual examination. The pouches may contain a cut or hole, which could compromise the sterility of the device. The FDA has classified this as a Class II recall.

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

The recalled product

Product
Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, 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 Filters
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 (9)

  • Lot numbers 61507
  • 61578
  • 61682
  • 61689
  • 61849
  • 61879
  • 62011
  • 62088
  • and 62108

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 →

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