Class 2 Device Recall AirLife

• Date Initiated by Firm: April 22, 2013
• Date Posted: August 13, 2013
• Recall Status: Terminated on June 16, 2015
• Recall Number: Z-1947-2013
• Recall Event ID: 64971
• 510(K)Number: K924610
• Product Classification: Ventilator, emergency, manual (resuscitator) - Product Code BTM
• Product: 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; ; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; ; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; ; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; ; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; ; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; ; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock; ; Product Usage: Pulmonary resuscitation
• Code Information: 1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668; 2) Product Code 2K8004; Lot Number: 0000355673; 3) Product Code 2K8017; Lot Numbers: 0000355676, 0000355677; 4) Product Code 2K8034; Lot Number: 0000355688; 5) Product Code 2K8035; Lot Number: 0000358023; 6) Product Code 2K8037; Lot Number: 0000358025; 7) Product Code 2K8040; Lot Number: 0000358026
• Recalling Firm/ Manufacturer: Carefusion 2200 Inc; 1500 S Waukegan Rd; Mpwm Bldg.; Waukegan IL 60085-6728
• For Additional Information Contact: Ms. Catherine Keck; 847-473-7097
• Manufacturer Reason for Recall: CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.
• FDA Determined Cause: Nonconforming Material/Component
• Action: CareFusion sent an URGENT RECALL NOTICE letter dated April 22, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to complete and return an attached Distributor Acknowledgement Form within fifteen (15) days of receipt indicating their acknowledgement of the URGENT RECALL NOTICE and indicate if they have any affected product on hand. They are further requested to perform a 100% physical inventory to verify if any of the affected product codes/lot numbers are in stock within their distribution network/facility. In addition, customers are requested to forward the Customer Acknowledgement Form, the Customer Notification Letter, the Certificate of Destruction Form, the Pictures of Location of Lot Numbers on Case/Product, and the Frequently Asked Questions (FAQs) to all end users which they have distributed the affected product. For questions call 847-473-7097.
• Quantity in Commerce: 14,112 units
• Distribution: US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA
• 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 = BTM and Original Applicant = ENGINEERED MEDICAL SYSTEMS