SmartSite Low Sorbing Infusion Set recall
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Why was SmartSite Low Sorbing Infusion Set recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. 14035485 14046894 14035458 14035457
- Product
- SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 5,600 units
- Distribution
- Distributed in the states of FL, NM, WA, WI, and TX.
- Recall date
- July 16, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)