| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00104-1 |
| Product Name/Description |
Unomedical ConvaTec Frazier Suction Handle (included in Foot Pack Health and Lower Extremity Procedure Packs)
Frazier Suction Handle
Product Code: UM1912
Lot Number: CGCA06-01
Foot Pack Health E Care Procedure Pack
Product Code: SOPSYML03D
Lot Numbers: CS1739694, CS1740778, CS1743999, CS1747123 and CS1857459
ARTG Number: 137395
Lower Extremity Procedure Pack
Product Code: SOPMESV06G
Lot Numbers: CS1741061, CS1742774 and CS1748561
ARTG Number 136870 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medline has been made aware of overseas complaints from users regarding swivelling of the suction tip of the handle of these devices. Depending on the type of procedure, there is a potential for serious harm such as delayed recovery/delay in treatment, and tissue damage. It is very likely that the user may still be able to continue suctioning even after the suction tip starts to swivel within the handle. The chances of detecting the swivel by the user remain high.
No complaints for this issue have been received to date in Australia. No patient harm has been reported as a result of this issue.
|
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Medline is advising users to inspect the Frazier suction handle for a loose tip prior to use. Additional/alternative Frazier units may be kept on standby just in case users experience swivelling of the suction tip.
The manufacturer is currently validating a revised manufacturing process after shifting the bending fulcrum of the bending fixture from the handle to the metal tube thus reducing the impact of the bending force on the handle. After successful validation and product testing, the revised product will be introduced to the market.
This action has been closed out on 19/09/2018 |
| Contact Information |
1800 110 511 - Customer Service Support |