Class 2 Device Recall Power circuit board assembly kits

• Date Initiated by Firm: February 22, 2008
• Date Posted: August 13, 2008
• Recall Status: Terminated on August 16, 2012
• Recall Number: Z-1470-2008
• Recall Event ID: 46850
• 510(K)Number: K981371 K984056 K002881 K010508 K040540
• Product Classification: Assembly kit - Product Code CBK
• Product: Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US. ; Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
• Code Information: Lot number: UK0335101, UK0400602, UK0404202, UK0408406, UK0410704, UK0412510, UK0424602, UK0427801, UK0430110, UK0433602, UK0504203, UK0508201
• Recalling Firm/ Manufacturer: Cardinal Health 203, Inc; 17400 Medina Rd Ste 100; Minneapolis MN 55447-1341
• Manufacturer Reason for Recall: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
• FDA Determined Cause: Device Design
• Action: An Urgent Medical Device Recall letter dated February 22, 2008 was sent to ventilator consignees/owners and distributors. The letter describes the issue, identifies the affected devices, states that the devices will be corrected by Cardinal Health and provides direction to verify ventilator operation and audible alarm function daily. Service Centers were provided information to identify affected printed circuit board assembly replacement kits' lot numbers and asked to return them. An "Update" was mailed 03/04/2008 to identify additional ventilator serial numbers that also need correction.
• Quantity in Commerce: 175 (OUS only)
• Distribution: Worldwide Distribution --- USA including Puerto Rico and countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, China Peoples Republic, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Panama, Paraguay, Philippines, Portugal, Saudi Arabia, Serbia & Montenegro, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and West Indies.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = PASCO LABORATORIES, INC.; 510(K)s with Product Code = CBK and Original Applicant = PULMONETIC SYSTEMS, INC.