Tracoe Experc Percut Dilation Sets
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Tracoe Experc Percut Dila Tracheo Set W/Trach/Atrau Insert Spiral Reinforce |
Not applicable. |
420-08 |
Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Extra-Long |
Not applicable. |
451-08-P |
Tracoe Experc Percut Dilation Tracheostomy Set W/Trach/Atraumatic Inserter |
Not applicable. |
460-09-P |
Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Fenestrate |
Not applicable. |
312-08-P |
Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Suct Line |
Not applicable. |
888-316-08-P |
Tracoe Experc Percut Dila Tracheo Set W/Trach/Atrau Inserter Sys Suct Line |
Not applicable. |
470-08-P |
Tracoe Experc Percut Dilation Tracheostomy Set W/Trach/Atraumatic Inserter |
Not applicable. |
330-08 |
Issue
Tracoe Medical GmbH is issuing a field safety notice for the above products as the application bears a low risk of tearing off the silicone sleeve when removing the insertion system. The incidence rate is 0.016 % and may be further minimized if the application is performed as described in the IFU.
Recall start date: October 27, 2022
Additional information
Details
Tracoe Medical GmbH
Reichelsheimer Str.1/3, Nieder-Olm, Germany, 55268
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