Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210
This recall has been terminated (originally issued March 29, 2006).
- Company
- Fisher & Paykel Healthcare Inc
- Recall Initiated
- December 20, 2005
- Posted
- March 29, 2006
- Terminated
- April 19, 2012
- Recall Number
- Z-0696-06
- Quantity
- 2175 boxes (21,750 pcs)
- Firm Location
- Laguna Hills, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide in AR, CA, FL, IL, LA, MN, NC, OH, SD, TX, UT, & VA. International distribution
Lot / Code Info
Affected lots for all catalogue numbers: 041101-050331(inclusive).
Root Cause
Other
Action Taken
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.
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