Shippert Medical Technologies recalls Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Ship…

Recall date

February 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1335-2019

FDA classification

Class II

Brand / firm

Shippert Medical Technologies

Sold / distributed

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,

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.