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Recall Observatory FDA recall evidence

Device product

namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

Z-1428-2025

February 12, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96367
Status
Ongoing
Classification
Class II
Quantity
4400 units
Official record key
device-enforcement:Z-1428-2025

Official wording

Reason: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

Code information: UDI/DI 10193489067507 (each), 20193489067504 (case), Lot number 0000140528

Distribution pattern: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.