| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01060-1 |
| Product Name/Description |
Disposable Expandable Adult 22mmID Expandable Anaesthetic Circuits
Part Numbers:
A3E120-700 - 120"/3m Length with Swivel Y Adaptor
A3E120-102 - 120"/3m Length with Fixed Y Adaptor and Mask Elbow
A3E120-100 - 120"/3m Length with Fixed Y Adaptor
A3E240-700 - 240"/6m Length with Swivel Y Adaptor
A3E120-702 - 120"/3m Length with Swivel Y Adaptor and Mask Elbow
Multiple Batch/Lot Numbers
ARTG Number: 188096 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
During a regular QA inspection, the manufacturer Mediplas identified an irregularity in the expandable tubing of specific batches of Disposable Expandable Adult 22mmID Expandable Anaesthetic Circuits. Due to this, all remaining unused circuits from the affected batches will be replaced with unaffected product without any additional cost to the customer. |
| Recall Action |
Recall |
| Recall Action Instructions |
Parker Healthcare is requesting that customers:
1. Isolate the unit(s) from the affected Batch(es)/Lot(s) and contact the Parker Healthcare Customer Service Team on 1300 361 201 or via email sales@parkerhealth.com.au to arrange the return of stock and the supply of replacement stock.
2. Complete the Facsimile/Email Reply Form supplied with the customer letter within 5 business days, even if you no longer have affected product, as this information is required to reconcile this process. If any of the recalled products have been transferred to another facility, please immediately let them know of this Recall, and record it on the Facsimile/Email Reply Form.
This action has been closed out on the 01/11/2018. |
| Contact Information |
1300 361 201 - Parker Healthcare Customer Service Team |