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Recall Observatory FDA recall evidence

Device product

Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) RETINAL INJECTION KIT, Pack Number MNS12465

Z-2777-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94586
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2777-2024

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: CIT6860A, Lot Number 2022011080; MNS12465, Lot Number 2021092780

Distribution pattern: Worldwide distribution.

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.