| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00447-1 |
| Product Name/Description |
Solus Flexible, wire-reinforced laryngeal mask airway
Small paediatric, wire-reinforced laryngeal mask airway 2
Large paediatric, wire-reinforced laryngeal mask airway 2.5
Small adult, wire-reinforced laryngeal mask airway 3
Medium adult, wire-reinforced laryngeal mask airway 4
Large adult, wire-reinforced laryngeal mask airway 5
Order Codes: 8002001, 8025001, 8003001, 8004001, 8005001
Lot Numbers: from 31310354 to 31700331
ARTG Number: 224554 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
An internal assessment by Intersurgical of product performance, including a review of customer complaints, has confirmed that specific Solus Flexible wire-reinforced laryngeal mask airway products have a manufacturing fault in the tube. This fault can result in partial or total occlusion of the airway tube when the cuff is inflated, which may result in partial or total restriction of air delivery to and/or from the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
Intersurgical is advising users to inspect their stocks and quarantine all units from the affected lot numbers, and to destroy these affected products. Credit will be arranged for this stock.
This action has been closed out on 14/11/2018 |
| Contact Information |
02 8048 3300 - Intersurgical Australia |