Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111
FDA Recall Z-0695-06 · Posted 2006-03-29
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Recalling FirmFisher & Paykel Healthcare Inc
Recall StatusTerminated
Product CodeBTT
Date Initiated2005-12-20
Date Terminated2012-04-19
Product Quantity260 boxes (2,600 pcs)
Reason for Recall
Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
Firm Action
On December 20th, 2005 the firm sent the notification letter instructing consignees to check and destroy any stock in the affected lot range. A fax-back Device Recall Response Form was included with the letter and will be used for the company''s effectiveness checks.
Root Cause
Other
Distribution Pattern
Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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