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Recall Observatory FDA recall evidence

Device product

154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Z-0958-2021

December 02, 2020

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 86973
Status
Terminated
Classification
Class II
Quantity
Total Kits = 7,500 for all four lots
Official record key
device-enforcement:Z-0958-2021

Official wording

Reason: Due to the incorrect filter assembly.

Code information: Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to the incorrect filter assembly.