Breathing circuit swivel elbow recall due to risk of cracks forming before or during use
(Source: Medicines & Healthcare products Regulatory Agency (MHRA)
Manufactured by Intersurgical, used in devices made by other companies: cracks in swivel elbow connectors may lead to prescribed ventilation not being delivered.
Note that the swivel elbow is a component used in a number of breathing circuits, distributed by several companies.
- Immediately quarantine all affected lot numbers listed in Field Safety Notice 1 (FSN1) from Intersurgical and FSN2 from Breas Medical and do not use.
- Contact the manufacturer of the identified devices using the response form on the appropriate FSN to arrange collection or confirm the destruction of all affected devices.
- If you do not have affected devices left in stock, confirm this with the corresponding manufacturer using the response form on their FSN
- Report suspected or actual adverse events involving
All healthcare professionals who are responsible for or who use these devices.
Deadlines for actions
Actions underway: 10 October 2019
Actions complete: 31 October 2019
Please note: CQC and OFSTED do not distribute these alerts.