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

FDA device recall Z-2025-2014 · posted 2014-07-09 · Terminated

Recall details

Recalling firm

CareFusion 303, Inc.

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

Action taken

A recall letter is dated 6/25/14 and will be sent out to customers who purchased 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 chamber. The letter informs the customers of the problems identified, potential risk, and actions to be taken. Customers are instructed to promptly complete and return the enclosed mandatory Customer Response Card to acknowledge the receipt of this communication and to expedite the corrective action process.

Root cause

Labeling Change Control

Status

Terminated

Product code

FPA

Quantity affected

5,600 units

Distribution

Distributed in the states of FL, NM, WA, WI, and TX.

Date initiated

2014-06-17

Date posted

2014-07-09

Date terminated

2016-09-20

Location

San Diego, CA

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