Recall Z-2218-2011
International Technidyne Corp. · initiated March 23, 2011
Product
AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated.
Codes / lots: AVOXimeter 1000: K922075 AVOX1000, AVOX1000E-110, AVOX1000INT AVOXimeter 4000: K951485 AVOX4000, AVOX4000D
Reason for recall
An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
FDA-determined cause: Device Design
Action taken
International Technidyne Corp. sent a letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they have any of the affected product. If they have any of the affected product, customers were instructed to stop using it and remove it from their inventory. Customers were also instructed to complete the attached Customer Account Tracking Form and return it by fax to (732-635-0144) or e-mail (techsupport@itcmed.com) or mail to: ITC Technical Support 20 Corporate Place South Piscataway, New Jersey 08854 For any questions call the Distributor or ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International), ext 4707.
Details
- Recall number
- Z-2218-2011
- Initiated
- March 23, 2011
- Posted by FDA
- May 19, 2011
- Terminated
- October 25, 2012
- Product code
- DQA – Oximeter
- Quantity
- 17
- Distribution
- Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand
- Recalling firm
- International Technidyne Corp., Edison, NJ