Known Identifiers & Locations
FEI Numbers
3005747797
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0039-2018 |
Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Reason: The knife handles slot depth is out of specification, so blades may not fit on the handles properly.
|
2014-09-26 |
Completed
|
View Details
|
| Z-0044-2017 |
Willy Rusch GmbH Tracheostomy Tube Set
Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Reason: The connector may disconnect from the tracheostomy tube during use.
|
2016-08-26 |
Terminated
|
View Details
|
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