Tracoe Experc Percut Dilation Sets
Brand(s)
Last updated
Summary
Product
Tracoe Experc Percut Dilation Sets
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
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. | 420-08 450-08-P 450-09-P 420-09 |
| Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Extra-Long | Not applicable. | 451-08-P 451-09-P 421-08 421-09 |
| Tracoe Experc Percut Dilation Tracheostomy Set W/Trach/Atraumatic Inserter | Not applicable. | 460-09-P 461-08-P 461-09-P 424-08 424-09 423-08 423-09 460-08-P |
| Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Fenestrate | Not applicable. | 312-08-P 331-08 312-09-P 331-09 |
| Tracoe Experc Percut Dilation Tracheo Set W/Trach/Atrau Inserter Suct Line | Not applicable. | 888-316-08-P 332-09 888-332-09 888-316-09-P 888-332-08 332-08 316-09-P 316-08-P |
| Tracoe Experc Percut Dila Tracheo Set W/Trach/Atrau Inserter Sys Suct Line | Not applicable. | 470-08-P 471-08-P 471-09-P 422-08 425-08 425-09 422-09 470-09-P |
| Tracoe Experc Percut Dilation Tracheostomy Set W/Trach/Atraumatic Inserter | Not applicable. | 330-08 311-08-P 330-09 311-09-P |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Tracoe Medical GmbH
Reichelsheimer Str.1/3, Nieder-Olm, Germany, 55268
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72228
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