Health product recall

Tracoe Experc Percut Dilation Sets

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: 2022-12-01
Alert / recall type
Health product recall
Category
Health product - Medical device - 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