International safety notice
Urgent field safety notice for ROTEM sigma complete + hep cartridge (Art. No. 555502), ROTEM sigma complete cartridge (Art. No. 555501) and recall of all ROTEM sigma complete cartridges (Art. No. 555501), TEM Innovations GmbH
Germany / BfArM · DEU · Mar 16, 2016
Key facts
| Title | Urgent field safety notice for ROTEM sigma complete + hep cartridge (Art. No. 555502), ROTEM sigma complete cartridge (Art. No. 555501) and recall of all ROTEM sigma complete cartridges (Art. No. 555501), TEM Innovations GmbH |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | ROTEM sigma complete + hep cartridge (Art. No. 555502), ROTEM sigma complete cartridge (Art. No. 555501) and recall of all ROTEM sigma complete cartridges (Art. No. 555501), TEM Innovations GmbH |
| Manufacturer | Urgent field safety notice for ROTEM sigma complete + hep cartridge (Art. No. 555502), ROTEM sigma complete cartridge (Art. No. 555501) and recall of all ROTEM sigma complete cartridges (Art. No. 555501), TEM Innovations GmbH |
| Models | 31.07.2016, 2016-03-11, 31.03.2016, 31.05.2016, 50602, 132082, 81829, 03.2016, 60936, 50603, 555501, 51003 and 18 more |
| Date | Mar 16, 2016 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1