Recall Z-2025-2014— CareFusion 303, Inc.

Name: FDA recall Z-2025-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-17

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2014-06-17, terminated 2016-09-20. It names one FDA 510(k) clearance: K944320. Product: SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458. Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c.

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-17
Terminated: 2016-09-20
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K944320 — VENTED/NON-VENTED GEMINI ADMINISTRATION SETImed Corp.·cleared 1995-02-14

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

SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458

Reason for recall

CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c

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