Recall Z-0832-2013— Carefusion 303 Inc

Name: FDA recall Z-0832-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-20

Class II · Terminated

Class II FDA medical device recall by Carefusion 303 Inc, initiated 2012-12-20, terminated 2013-07-25. It names one FDA 510(k) clearance: K882302. 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.. Reason: 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..

Recalling firm: Carefusion 303 Inc
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Terminated: 2013-07-25
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K882302 — IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080Y·cleared 1988-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.