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Recall Observatory FDA recall evidence

Device product

namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710

Z-1430-2025

February 12, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96367
Status
Ongoing
Classification
Class II
Quantity
100 units
Official record key
device-enforcement:Z-1430-2025

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 10193489070279 (each),20193489070276 (case), Lot number 0000141266

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.