Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall Z-1060-2008 · Posted 2008-04-24

Recalling FirmRespironics, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2007-10-15
Date Terminated2009-09-01
Product Quantity20950 units

Reason for Recall

Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Firm Action

The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.

Root Cause

Environmental control

Distribution Pattern

The products were shipped nationwide to medical facilities.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842876PORTABLE LIFECARE VENTILATOR PLV-102Lifecare Services, Inc. · 1984-08-29

Official Source

View FDA Recall →

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

↑