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U.S. Department of Health and Human Services

Class 2 Device Recall CareFusion SmartSite Gravity Blood Set

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 Class 2 Recall
CareFusion SmartSite Gravity Blood Set
see related information
Date Posted February 15, 2013
Recall Status1 Terminated on July 25, 2013
Recall Number Z-0832-2013
Recall Event ID 64204
Premarket Notification
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, California 92130-2622
Consumer Instructions No consumer action necessary
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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = Y
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