Intersurgical has issued an urgent product recall for specific One-Piece Guedel Airways (sizes 000 and 00) due to a manufacturing defect.
Some devices have been identified with fully or partially occluded tips, which may obstruct airflow. If an affected airway is used, there is a risk of respiratory compromise, including hypoxia and other serious patient harm.
Affected products
- One-Piece Guedel Airways – sizes 000 and 00
- Product codes:
- 1100050
- 1100050S
- 8100050
- 1000035
- 1000035S
- 8000035
Affected stock: All lot numbers with expiry dates between 2026-06 and 2031-02.
Action Required
Please take the following actions immediately:
- Identify all affected products in your department and remove it from clinical use.
- Notify all relevant clinical staff of this recall.
- Complete the manufacturer's reply form, even if no affected stock is held.
- Confirm whether affected stock has been destroyed or requires collection so that credit can be arranged.
Further Information
Please refer to the manufacturer's Field Safety Notice for the full details, including affected product codes, expiry dates, images of the defect and the customer reply form.
Questions
For queries regarding this recall, please contact the Manufacturer:
Intersurgical Ltd.
Email: [email protected]
Telephone: 0118 965 6300
Priority
Critical – Immediate action required
Affected stock must be identified and quarantined immediately upon receipt of this alert. This is a manufacturer product recall due to the potential for critical patient harm if an occluded airway is used.