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Recall Observatory FDA recall evidence

Device product

MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J

Z-0642-2025

October 09, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95621
Status
Ongoing
Classification
Class II
Quantity
336 units
Official record key
device-enforcement:Z-0642-2025

Official wording

Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Code information: 1) REF DYNJ0531985R, UDI/DI 10195327216405 (each) 40195327216406 (case), Lot Numbers: 22HMF853, 23CMA603, 22LMG691; 2) REF DYNJ0843760I, UDI/DI 10195327365141 (each) 40195327365142 (case), Lot Numbers: 23DDA645; 3) REF DYNJ0843760J, UDI/DI 10195327491369 (each) 40195327491360 (case), Lot Numbers: 23JDA821

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.