The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1334-2019·Announced 2019-05-22

Shippert Medical Technologies Recalls Tissu-Trans FILTRON 2000 Medical Devices

Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 2000 sterile, disposable, one-patient use devices due to a Class II classification.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report specific injuries or illnesses, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Shippert Medical Technologies is voluntarily recalling 6,553 units of Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000. The product is a sterile, disposable, one-patient use medical device. The recall was initiated by the firm on February 2, 2018, and is classified as Class II by the FDA.

The affected 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 specific reason for the recall is not detailed in the provided source text.

The recall status is marked as completed. Affected lot codes include 61688, 61759, 61846, 61847, and 61848. The firm notified customers via letter. Consumers and healthcare providers should check their inventory for these specific catalog and lot numbers and follow the firm's instructions for return or disposal.

The recalled product

Product
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, 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 (5)

  • 61688
  • 61759
  • 61846
  • 61847
  • and 61848

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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