Device product
Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Z-1336-2019
Product summary
- Event
- Event 81837
- Status
- Completed
- Classification
- Class II
- Quantity
- 6,553 units were distributed for all catalog numbers
- Official record key
device-enforcement:Z-1336-2019
Official wording
Reason: 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.
Code information: 61656
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,
Derived failure modes
-
Unknown
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.