FDA recall Z-1335-2019

Shippert Medical Technologies · Class II · device

Product

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.

Reason for recall

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.

Distribution

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,

Key facts

Status
Completed
Initiation date
2018-02-02
Report date
2019-05-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Centennial, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1335-2019