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Terminated

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.

FDA Recall Z-0832-2013 · Posted 2013-02-15

Recalling FirmCarefusion 303 Inc
Recall StatusTerminated
Product CodeFPA
Date Initiated2012-12-20
Date Terminated2013-07-25
Product Quantity5,050 units

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.

Firm 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).

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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