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Recall – Breas Medical, INC 

By January 24, 2024Recalls

About the Recall:

This recall was issued duet to a field safety notice from Intersurgical Ltd., the manufacturer of the NIV Angled Mouthpiece with Notch 22F/15F, indicating some lots were produced with unintended open slits on the side of the mouthpiece body.  This allows some of the respiratory gas to escape and thus reduces effectiveness of the related Vivo 45 LS US device.
Risk to Health
Breas Medical has estimated that it is not likely that use of defective mouthpieces will cause any adverse event due to the effectiveness of existing risk mitigations.

Products(s) numbers/models that are affected:

Name: Intersurgical NIV Angled Mouthpiece Product Number: 006093, 006653 Lot/Serial Number: 32304444, 32305269, 32306017

Manufacturer Notice/Web Site:

Actions to be taken by customer/Patient:

Inspect your mouthpiece to determine if it is defective.  If you have a defective mouthpiece, discontinue use, and contact your home medical equipment provider for replacement.