Z-0832-2013Class II

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a...

Name: Z-0832-2013 CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a...
Creator: Carefusion 303 Inc
Published: 2012-12-20
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2012-12-20 / Terminated / root cause: manufacturing process

FDA source

Carefusion 303 Inc began a recall of CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's... on 2012-12-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0832-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-20
Posted: 2013-02-15
Terminated: 2013-07-25
Recalling firm: CareFusion 303, Inc
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.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lot number 12055225

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0832-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0832-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-15

Product code FPA

K882302Class IIIvac(r) Unvented Vol. Infusion Set Model 52080Y / cleared 1988-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)