FDAClass IIFebruary 17, 2021

60" (152 cm) Appx recall

60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The…

Why was 60" (152 cm) Appx recalled?

Due to the incorrect filter assembly.

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?

Model List Number: MC330174 UDI: (01)10887709079974(17)250401(30)50(10)4799374 Lot Number: 4799374

Product
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The…
Recalling firm
ICU Medical, Inc.
Quantity
Total Kits = 7,500 for all four lots
Distribution
Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium.
Recall date
February 17, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls