Z-1333-2019 Class II
FDA device recall Z-1333-2019 was initiated by Shippert Medical Technologies on February 2, 2018 and is designated Class II. Affected quantity: 6,553 units were distributed for all catalog numbers.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- February 2, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,553 units were distributed for all catalog numbers
Product 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.
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,
Code Information
61627, 61687, 61839, 61920, 62051, and 62087