Field Safety Notice
19.03.2021
Intersurgical Ltd have received complaints where a product that should contain an Adult EcoliteTM Aerosol Mask with vents/exhalation ports, has been found to contain a similar mask without vents/exhalation ports, this would prevent the patient breathing normally. If a mask without vents/exhalation ports is not identified and subsequently used on a patient, in situations where the patient cannot or does not remove the mask themselves this could result in distress, harm or potential fatality. It would also prevent the intended treatment being provided to the patient.
The affected products' details are as follows:
PIP Code | Product Description | Supplier | Affected Batch |
0823484 | CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M, 1453015 | INTERSURGICAL LTD | 32053274 32052973 |
Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.
This Field Safety Notice will remain open for 3 months from the date issued unless an alternative date is agreed by instigator. The closure of this will be 16/06/2021. Please note after this date customer returns may still be accepted but customers may not be credited.
Recipients of this Drug Alert should bring it to the attention of relevant contacts.
If you have any questions, then please contact your local Service Centre Customer Services team