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Recall Observatory FDA recall evidence

Device product

MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A

Z-0644-2025

October 09, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95621
Status
Ongoing
Classification
Class II
Quantity
828 units
Official record key
device-enforcement:Z-0644-2025

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 DYNJ16826O, UDI/DI 10195327412067 (each) 40195327412068 (case), Lot Numbers: 23FMC064; 2) REF DYNJ64432, UDI/DI 10193489814255 (each) 40193489814256 (case), Lot Numbers: 22CDC116, 22DDC463, 22JDA234, 22KDA275, 23BDA297, 23DDC249, 23FDB680; 3) REF DYNJ906909A, UDI/DI 10195327303532 (each) 40195327303533 (case), Lot Numbers: 23DBD597, 23DBE346, 23ABE857, 23KBH128, 23IBC034, 24ABT698

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.