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Recall Observatory FDA recall evidence

Device product

Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098

Z-1393-2025

February 11, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96372
Status
Ongoing
Classification
Class II
Quantity
456 kits
Official record key
device-enforcement:Z-1393-2025

Official wording

Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Code information: 1) 10195327273132 (each) 40195327273133 (case), Lot Number 23GBK039Z

Distribution pattern: Worldwide - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.