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Recall Observatory FDA recall evidence

Device product

Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen

Z-1871-2025

May 02, 2025

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 96783
Status
Ongoing
Classification
Class II
Quantity
1710
Official record key
device-enforcement:Z-1871-2025

Official wording

Reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

Code information: UDI-DI (ea) 10192253040296; UDI-DI (box) 50192253040294 Lots 2433100060 2433100059 2422700145 2422700139 2422700146 2422700142

Distribution pattern: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Canada, Chile, Colombia, Singapore, South Africa.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Packaging defect
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Packaging defect may compromise sterility of the product. Use of a non-sterile