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Recall Observatory FDA recall evidence

Device product

Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PACK-LF, Pack Number DYNJ0046667A

Z-1450-2025

February 11, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96374
Status
Ongoing
Classification
Class II
Quantity
570 units
Official record key
device-enforcement:Z-1450-2025

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) Pack Number DYNJ65616C: UDI/DI 10195327470869 (each) 40195327470860 (case), Lot Number 23LMF217A; 2) Pack Number DYNJ61371A: UDI/DI 10193489796803 (each) 40193489796804 (case), Lot Number 21FMA140A; 3) Pack Number DYNJ20720C: UDI/DI 10884389620564 (each) 40884389620565 (case), Lot Number 21EMF438A; 4) Pack Number DYNJ0415776N: UDI/DI 10193489413984 (each) 40193489413985 (case), Lot Number 22CMD073A; 5) Pack Number PHS656483I: UDI/DI 10889942806768 (each) 40889942806769 (case), Lot Number 23GMB728A; 6) Pack Number DYNJ0046667A: UDI/DI 10889942160396 (each) 40889942160397 (case), Lot Number 22CMD979A

Distribution pattern: Worldwide distribution - 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.