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Recall Observatory FDA recall evidence

Device product

REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: 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-1588-2021

March 16, 2021

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 87703
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1588-2021

Official wording

Reason: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Code information: REF: CH3235 UDI: (01) 1 0840619 03403 7 (17) 260101 (30) 50 (10) 5125276 Lot Number: 5125276

Distribution pattern: Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.