MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2024 - (Recall #: Z-3121-2024)

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D; c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F; d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C; e) LAMINECTOMY, Pack Number DYNJ908091B; f) PODIATRY, Pack Number DYNJ908092C; g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B; h) CRANI, Pack Number DYNJ908097A; i) HIP PINNING, Pack Number DYNJ908102B; j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B; k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B; m) HAND-LF, Pack Number DYNJ908425; n) TOTAL JOINT, Pack Number DYNJ908660A; o) MERCY TIFFIN HAND, Pack Number DYNJ909734; p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738; q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740; r) ACL-WHSC, Pack Number DYNJ910074A; s) EXTREMITY-WHSC, Pack Number DYNJ910077; t) EXTREMITY-WHSC, Pack Number DYNJ910077A; u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A; v) MICRODISC, Pack Number DYNJ910370; w) MTHZ TOTAL HIP, Pack Number DYNJC9311L

Class II

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.

a) CDS981510L: UDI/DI case 40195327195435, UDI/DI each 10195327195434, Lot Numbers: 23LDB386, 23LDB793; b) DYNJ900720D: UDI/DI case 40193489951593, UDI/DI each 10193489951592, Lot Numbers:23LBT897; c) DYNJ900720F: UDI/DI case 40195327635337, UDI/DI each 10195327635336, Lot Numbers: 24CBC838, 24EBH235; d) DYNJ908090C: UDI/DI case 40195327507245, UDI/DI each 10195327507244, Lot Numbers: 24CBH612, 24FBA023; e) DYNJ908091B: UDI/DI case 40195327507023, UDI/DI each 10195327507022, Lot Numbers: 24CBK626; f) DYNJ908092C: UDI/DI case 40195327507030, UDI/DI each 10195327507039, Lot Numbers: 23LBU932, 24ABT063, 24CBP714; g) DYNJ908095B: UDI/ DI case 40195327507184, UDI/DI each 10195327507183, Lot Numbers: 24ABO437, 24ABW989, 24EBH236; h) DYNJ908097A: UDI/DI case 40195327507078, UDI/DI each 10195327507077, Lot Numbers:23LBV779, 24CBU878; i) DYNJ908102B: UDI/DI case 40195327507191, UDI/DI each 10195327507190, Lot Numbers: 24BBI407; j) DYNJ908103B: UDI/DI case 40195327507108, UDI/DI each 10195327507107, Lot Numbers: 24CBO655; k) DYNJ908110B: UDI/DI case 40195327507160, UDI/DI each 10195327507169, Lot Numbers: 24ABS361, 24CBE409; m) DYNJ908425: UDI/DI case 40195327072613, UDI/DI each 10195327072612, Lot Numbers: 24ABL204; n) DYNJ908660A: UDI/DI case 40195327219674, UDI/DI each 10195327219673, Lot Numbers: 23LMC113, 24AME301, 24AMJ018, 24CMH075; o) DYNJ909734: UDI/DI case 40195327464708, UDI/DI each 10195327464707, Lot Numbers: 24ABA222, 24CBO720; p) DYNJ909738: UDI/DI case 40195327464739, UDI/DI each 10195327464738, Lot Numbers: 24ABY029, 4EBH232; q) DYNJ909740: UDI/DI case 40195327464753, UDI/DI each 10195327464752, Lot Numbers: 24BBK598; r) DYNJ910074A: UDI/DI case 40195327639281, UDI/DI each 10195327639280, Lot Numbers: 24CBA353; s) DYNJ910077: UDI/DI case 40195327568383, UDI/DI each 10195327568382, Lot Numbers: 23LBS081; t) DYNJ910077A: UDI/DI case 40195327639342, UDI/DI each 10195327639341, Lot Numbers: 24CBM378, 24DBC165; u) DYNJ910080A: UDI/DI case 40195327639304, UDI/DI each 10195327639303, Lot Numbers: 24BBS375; v) DYNJ910370: UDI/DI case 40195327654536, UDI/DI each 10195327654535, Lot Numbers: 24DDB322, 24EDA091; w) DYNJC9311L: UDI/DI case 40195327464777, UDI/DI each 10195327464776, Lot Numbers: 24CDC175

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Voluntary: Firm initiated