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Terminated

Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators

FDA Recall Z-2550-2016 · Posted None

Recalling FirmResmed Corporation
Recall StatusTerminated
Product CodeBZD
Date Initiated2016-07-12
Date Terminated2016-09-26
Product Quantity42 units

Reason for Recall

Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.

Firm Action

An urgent product recall notification letter was sent to all customers on 7/12/16 to inform them that ResMed is recalling NV Quattro Air & Quattro Air Mask due to a mislabeling Issue. The letter informs the customers that during the investigation of a product complaint, ResMed identified that a small number of masks labelled and sold as 62702 Quattro Air FFM MED AMER, Lot 1142623 actually contain an NV Quattro Air FFM Large mask. The letter informs the customers to notify anyone they may have sold the products to. Customers with any questions are instructed to call the ResMed Customer Service team: 858-836-5968.

Root Cause

Packaging process control

Distribution Pattern

US nationwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123979QUATTRO AIRResmed, Ltd. · 2013-02-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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