CareFusion 303, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0221-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

Product Classification:

Class II

Date Initiated: October 9, 2015

Date Posted: November 11, 2015

Recall Number: Z-0221-2016

Event ID: 72384

Reason for Recall:

CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.

Status: Terminated

Product Quantity: 21,000 units

Code Information:

Lot No. 15015769, 15035412, 15045950.

Distribution Pattern:

Distributed US (nationwide) and in Canada.

Voluntary or Mandated:

Voluntary: Firm initiated