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Recall Observatory FDA recall evidence

Device product

MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D

Z-0623-2025

October 09, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95621
Status
Ongoing
Classification
Class II
Quantity
182 units
Official record key
device-enforcement:Z-0623-2025

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 DYNJ0572894I, UDI/DI 10195327045975 (each) 40195327045976 (case), Lot Numbers: 22EBV549, 22FBV442, 23ABU908, 22LBG711, 23CBJ089, 23BBM090, 23GBS959, 23JBG841; 2) REF DYNJ34418L, UDI/DI 10193489969276 (each) 40193489969277 (case), Lot Numbers: 23CBT026, 23ABO601; 3) REF DYNJ34418M, UDI/DI 10195327384371 (each) 40195327384372 (case), Lot Numbers: 23GBA504; 4) REF DYNJ900287D, UDI/DI 10193489798289 (each) 40193489798280 (case), Lot Numbers: 23BBT640, 23FBF622, 23GBL588, 23FBV779, 23EBF038,

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.