Device Recall SmartSite Low Sorbing Infusion Set 의 리콜

Recall

68608

Class 2

Z-2025-2014

2014-06-17

2014-07-09

Terminated

United States

2016-09-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128305

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.

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.