| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01268-1 |
| Product Name/Description |
Various Disposable Catheter Mounts
Disposable Catheter Mount, Dble Swvl Elbow w Suction Port & Adaptor 15M
Part Number: 6000-40(D)
Disposable Catheter Mount Dble Swvl Elbw w Suction Port & Adaptor 15M Sterile
Part Number: 6000-40(D)/S
Disposable Catheter Mount, Dble Swvl Elbow w Suction Port & Adaptor 22F
Part Number: 6000-41(D)
Double Swvl Elbw w Suction Port and Cap 15mmM to 22mmM/15mmF Sterile PP
Part Number: PH71522/S
Multiple Batch Numbers
ARTG Number: 188096 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Parker Healthcare are recalling the affected stock due to a potential obstruction within the swivel elbow adaptor. If component is obstructed, it would restrict the gas flow to the patient and may lead to serious health consequences. Two incidents of faulty catheter mounts have been reported. However, to date, no injuries have occurred. |
| Recall Action |
Recall |
| Recall Action Instructions |
Parker Healthcare are advising users to inspect stock and quarantine any affected units. Affected stock can be returned to Parker for replacement with unaffected product.
This action has been closed out on 01/11/2018 |
| Contact Information |
1300 361 201 – Parker Healthcare Customer Service Team |