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Terminated

RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.

FDA Recall Z-0326-05 · Posted 2004-12-17

Recalling FirmMedical Industries America Inc
Recall StatusTerminated
Product CodeBZD
Date Initiated2004-09-03
Date Terminated2005-08-18
Product Quantity74 units

Reason for Recall

Units could show an error code and stop functioning.

Firm Action

The recall was initiated via telephone on 9/3/04 to their customers explaining the reason for recall and instructing them to hold the units for further instruction. A telephone call to the customers on 9/10/04 instructed them to return the units for correction and replacement and to notify the end users.

Root Cause

Other

Distribution Pattern

Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign distribution was made to Hong Kong, Chile, and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002763REMRESTMedical Industries America, Inc. · 2001-05-04

Official Source

View FDA Recall →

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

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