Class 2 Device Recall CareFusion SmartSite Gravity Blood Set

• Date Initiated by Firm: December 20, 2012
• Date Posted: February 15, 2013
• Recall Status: Terminated on July 25, 2013
• Recall Number: Z-0832-2013
• Recall Event ID: 64204
• 510(K)Number: K882302
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
• Code Information: Lot number 12055225
• Recalling Firm/ Manufacturer: Carefusion 303 Inc; 3750 Torrey View Ct; San Diego CA 92130-2622
• Manufacturer Reason for Recall: CareFusion is recalling the SmartSite Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Carefusion sent an "URGENT: Medical Device Recall Notification" letter dated January 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to return all recalled product directly to the distributor from whom it was purchased immediately, complete and return the enclosed pre-addressed and postage paid mandatory Customer Recall Response Card and to contact your distributor directly, or call the Carefusion Support Center, if you have any questions. For questions Recall Related Questions contact CareFusion Support Center at 888-562-6018; 7am to 4pm (Pacific). For technical questions contact Technical Support at 888-812-3229, 7am to 5pm (Pacific).
• Quantity in Commerce: 5,050 units
• Distribution: Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
• 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 = FPA