FDA Recall
Completed
Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Recall: Z-1333-2019
·
Initiated February 2, 2018
Recall
- Recall Number
- Z-1333-2019
- Event Number
- 81837
- Firm
- Shippert Medical Technologies
- FEI Number
- 3008719017
- Product Code
- MUU
- Status
- Completed
- Root Cause
- Packaging process control
- Initiated
- February 2, 2018
- Address
- 6248 S Troy Cir, Ste A, Centennial, CO, 80111-6485
Description
Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Action
Letters dated 1/9/2018 were issued beginning 2/2/2018 via registered mail and Fed Ex explaining the reason for recall, risk to health, description of how to recognize the device failed, and actions to be taken.
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,
Quantity
6,553 units were distributed for all catalog numbers