| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00114-1 |
| Product Name/Description |
Use of Tristel Trio Wipes System with GE TEE probe
Affected Product: TEE probe models: 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RS
Multiple probe types and part numbers
ARTG Number:123916
(GE Medical Systems Australia - Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
The Tristel Trio Wipes System has been validated for efficacy and residual toxicity for TEE probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans.
Further testing has identified a need for clarification of the previously communicated disinfection guidance for GE TEE Probes regarding use of the Tristel Trio Wipes system.
Specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods using Tristel Trio Wipes may not always be effective when used in connection with procedures that have long TEE probe intubation times, such as cardiac surgeries, and/or with TEE probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe. GE recommends the additional use of a sterile sheath covering the TEE probe when Tristel Trio Wipes are being used as the sole method of disinfection. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Under conditions where the TEE probe has a long intubation time or shows visible signs of wear and damage, GE recommends the use of a sterile sheath covering the TEE probe in addition to disinfection using the Tristel Trio Wipes System.
This action has been closed out on 07/11/2018 |
| Contact Information |
1800 659 465 - Customer Service Support |