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FDA (Device enforcement)Recalled 2024-10-09class ii

MEDLINE INDUSTRIES, LP - Northfield: MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259

Hazard

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

Details from the source

Reason for recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Distribution: US Nationwide distribution. Quantity: 24754 units Lot/code info: 1) REF CDS983184I, UDI/DI 10195327178352 (each) 40195327178353 (case), Lot Numbers: 22LBB795, 23FBJ754, 23BBH106, 23CBT619, 23HBY087, 23HBP974, 23KBI669, 23LBD939, 23KBM394; 2) REF CDS983466L, UDI/DI 10195327497217 (each) 40195327497218 (case), Lot Numbers: 23JDB850, 23IDB539, 23KDB596, 24DDB278, 24DDA871, 24BDA878, 24ADA819, 24CDB315; 3) REF CDS983486K, UDI/DI 10195327497200 (each) 40195327497201 (case), Lot Numbers: 23JDA349, 24CDA873, 24ADA731, 24ADB821; 4) REF CDS984259N, UDI/DI 10193489862232 (each) 40193489862233 (case), Lot Numbers: 22KBJ788, 22JBH993, 22JBH284, 22LBB413; 5) REF CDS984259O, UDI/DI 10195327297817 (each) 40195327297818 (case), Lot Numbers: 23ABM783, 23ABK571; 6) REF CDS984282L, UDI/DI 10195327438920 (each) 40195327438921 (case), Lot Numbers: 23LMA461; 7) REF CDS984895I, UDI/DI 10193489983814 (each) 40193489983815 (case), Lot Numbers: 22FBL382, 22KBD792, 23DBM334, 23ABM451, 23FBK273; 8) REF CDS984895J, UDI/DI 10195327469092 (each) 40195327469093 (case), Lot Numbers: 23KBH104, 23KBH045; 9) REF CDS984895K, UDI/DI 10195327620875 (each) 40195327620876 (case), Lot Numbers: 24BBQ203, 24CBM385; 10) REF DYNJ0101206D, UDI/DI 10195327028855 (each) 40195327028856 (case), Lot Numbers: 22EMG943, 22GMB620; 11) REF DYNJ0101206F, UDI/DI 10195327269470 (each) 40195327269471 (case), Lot Numbers: 22KMB120, 22KMB121, 23EMB091, 23DMB727, 23BMD165, 23FMD066, 23GMH580, 23JMA281, 23KBV062, 24ABN126, 24DBT379, 24DBD204; 12) REF DYNJ0101314D, UDI/DI 10195327286453 (each) 401953272

UPC codes

10195327178352, 40195327178353, 10195327497217, 40195327497218, 10195327497200, 40195327497201, 10193489862232, 40193489862233, 10195327297817, 40195327297818, 10195327438920, 40195327438921, 10193489983814, 40193489983815, 10195327469092, 40195327469093, 10195327620875, 40195327620876, 10195327028855, 40195327028856, 10195327269470, 40195327269471, 10195327286453, 40195327286454, 10195327295813, 40195327295814, 10195327332952, 40195327332953, 10195327124755, 40195327124756, 10195327216627, 40195327216628, 10195327248031, 40195327248032, 10195327416065, 40195327416066, 10195327304294, 40195327304295, 10195327304300, 40195327304301

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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