Shippert Medical Technologies recalls Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is

Recalled May 22, 2019 · FDA recall Z-1330-2019 · Shippert Medical Technologies

Hazard

The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch. · FDA Class II

Units

6,553 units were distributed for all catalog numbers

Sold at

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,

Description

The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

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(s)

Shippert Medical Technologies

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →