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Terminated

RT130 and RT131 Neonatal/ Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier.

FDA Recall Z-0553-05 · Posted 2005-02-18

Recalling FirmFisher & Paykel Healthcare Inc
Recall StatusTerminated
Product CodeBTT
Date Initiated2004-12-21
Date Terminated2005-11-21
Product Quantity2200

Reason for Recall

Pressure elbow may be partly occluded.

Firm Action

Recall was initiated on 12/17/2004 at all firm locations and distributors worldwide. The recall letter includes instructions for performing a mitigation until new stock is supplied.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020332RESPIRATORY HUMIDIFIER, MODEL MR850Fisher & Paykel Healthcare, Ltd. · 2003-07-07

Official Source

View FDA Recall →

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

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