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Recall Observatory FDA recall evidence

Device 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.

Z-1334-2019

February 02, 2018

Class II

Product summary

Firm
Shippert Medical Technologies
Event
Event 81837
Status
Completed
Classification
Class II
Quantity
6,553 units were distributed for all catalog numbers
Official record key
device-enforcement:Z-1334-2019

Official wording

Reason: Unavailable

Code information: 61688, 61759, 61846, 61847, and 61848

Distribution pattern: Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,