CanadaCardinal Health Presource® kits containing the Ritmed® Neurological Sponges are affected; affected items include Orthopaedic (Ortho) Spine Packs (models SOP30SP'XXX' and SNE30SP'XXX'), Head and Neck packs (SEN30HN'XXX'), Vascular packs (SCV30VAFHS) and Burr Hole packs (SNE30BHXXX) with multiple listed lot numbers (for example: 498644, 392650, 426499, 435000, 699880, 716193, 304629). They were recalled because of unexpected variability of endotoxin levels on the products; contact the manufacturer for additional information.
What's being recalled
Companies: Cardinal Health 200, LLC Also Trading As Cardinal Health, 3651 Birchwood Drive, Waukegan, Illinois, United States, 60085.
How to identify it
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 498644; Model or catalogue number: SOP30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 392650; Model or catalogue number: SOP30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 426499; Model or catalogue number: SOP30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 435000; Model or catalogue number: SOP30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 699880; Model or catalogue number: SNE30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 716193; Model or catalogue number: SNE30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 304629; Model or catalogue number: SNE30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 736240; Model or catalogue number: SNE30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 260104; Model or catalogue number: SNE30SP'XXX'
Affected products: Orthopaedic (Ortho) Spine Packs; Lot or serial number: 724406; Model or catalogue number: SNE30SP'XXX'
Affected products: Head and Neck Packs; Lot or serial number: 498623; Model or catalogue number: SEN30HN'XXX'
Affected products: Head and Neck Packs; Lot or serial number: 478469; Model or catalogue number: SEN30HN'XXX'
Affected products: Head and Neck Packs; Lot or serial number: 395935; Model or catalogue number: SEN30HN'XXX'
Affected products: Head and Neck Packs; Lot or serial number: 380936; Model or catalogue number: SEN30HN'XXX'
Affected products: Head and Neck Packs; Lot or serial number: 389664; Model or catalogue number: SEN30HN'XXX'
Affected products: Vascular Pack; Lot or serial number: 403392; Model or catalogue number: SCV30VAFHS
Affected products: Vascular Pack; Lot or serial number: 396012; Model or catalogue number: SCV30VAFHS
Affected products: Burr Hole Packs; Lot or serial number: 406257; Model or catalogue number: SNE30BHXXX
Affected products: Burr Hole Packs; Lot or serial number: 468614; Model or catalogue number: SNE30BHXXX
Affected products: Burr Hole Packs; Lot or serial number: 483555; Model or catalogue number: SNE30BHXXX
Affected products: Burr Hole Packs; Lot or serial number: 424226; Model or catalogue number: SNE30BHXXX
Affected products: Burr Hole Packs; Lot or serial number: 386222; Model or catalogue number: SNE30BHXXX
Affected products: Sinus Pack; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30EN'XXX'
Affected products: Sinus Pack; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30SI'XXX'
Affected products: Septoplasty Procedural Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30NSXXX
Affected products: Laminectomy Packs; Lot or serial number: 664226; Model or catalogue number: SNE30LMWTG
Affected products: Laminectomy Packs; Lot or serial number: 694351; Model or catalogue number: SNE30LMWTG
Affected products: Laminectomy Packs; Lot or serial number: 716192; Model or catalogue number: SNE30LMWTG
Affected products: Laminectomy Packs; Lot or serial number: 506787; Model or catalogue number: SNE30LMWTF
Affected products: Laminectomy Packs; Lot or serial number: 532491; Model or catalogue number: SNE30LMWTF
Affected products: Laminectomy Packs; Lot or serial number: 582580; Model or catalogue number: SNE30LMWTF
Affected products: Laminectomy Packs; Lot or serial number: 596894; Model or catalogue number: SNE30LMWTF
Affected products: Laminectomy Packs; Lot or serial number: 411428; Model or catalogue number: SNE30LPYCP
Affected products: Laminectomy Packs; Lot or serial number: 398293; Model or catalogue number: SNE30DL10C
Affected products: Laminectomy Packs; Lot or serial number: 406259; Model or catalogue number: SNE30DL10C
Affected products: Basic Plastic Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SBA30PL'XXX'
Affected products: Transphenoidal Packs; Lot or serial number: 406264; Model or catalogue number: SEN30EN'XXX'
Affected products: Transphenoidal Packs; Lot or serial number: 406264; Model or catalogue number: SNE30TR'XXX'
Affected products: Craniotomy Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30CNXXX
Affected products: Craniotomy Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30CRXXX
Affected products: Craniotomy Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30PCXXX
Affected products: Breast Packs; Lot or serial number: 411410; Model or catalogue number: SBA30TR'XXX'
Affected products: Breast Packs; Lot or serial number: 478443; Model or catalogue number: SBA30TR'XXX'
Affected products: Eye Kit; Lot or serial number: 450173; Model or catalogue number: SEY30EYRVC
Affected products: Eye Kit; Lot or serial number: 422397; Model or catalogue number: SEY30EYRVC
Affected products: Eye Kit; Lot or serial number: 401238; Model or catalogue number: SEY30EYRVC
Affected products: Ensemble Colonne; Lot or serial number: 460994; Model or catalogue number: SNE30SPXXX
Affected products: Ensemble Colonne; Lot or serial number: 514728; Model or catalogue number: SNE30SPXXX
Affected products: Ensemble Colonne; Lot or serial number: 503592; Model or catalogue number: SNE30SPXXX
Affected products: Ensemble Colonne; Lot or serial number: 406167; Model or catalogue number: SNE30SPXXX
Affected products: Spinal Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30SPVHB
Affected products: Spinal Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30SPVHA
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30ENXXX
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30KH'XXX'
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30BS'XXX'
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30CR'XXX'
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30NP'XXX'
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30DB'XXX'
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30NE'XXX'
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30NUMGL
Affected products: Neurology Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30NUMGM
Affected products: Lumbar Discoidectomy (Discoidectomie Lombaire) Packs; Lot or serial number: 398251; Model or catalogue number: SNE30LDXXX
Affected products: Lumbar Discoidectomy (Discoidectomie Lombaire) Packs; Lot or serial number: 406260; Model or catalogue number: SNE30LDXXX
Affected products: Lumbar Discoidectomy (Discoidectomie Lombaire) Packs; Lot or serial number: 495020; Model or catalogue number: SNE30LDXXX
Affected products: Lumbar Discoidectomy (Discoidectomie Lombaire) Packs; Lot or serial number: 385385; Model or catalogue number: SOP30DLXXX
Affected products: Lumbar Discoidectomy (Discoidectomie Lombaire) Packs; Lot or serial number: 461171; Model or catalogue number: SOP30DLXXX
Affected products: Lumbar Discoidectomy (Discoidectomie Lombaire) Packs; Lot or serial number: 483853; Model or catalogue number: SOP30DLXXX
Affected products: Lumbar Discoidectomy (Discoidectomie Lombaire) Packs; Lot or serial number: 497899; Model or catalogue number: SOP30DLXXX
Affected products: Facial Surgery Packs; Lot or serial number: 426081; Model or catalogue number: SBA30MFXXX
Affected products: DBS (Deep Brain Stimulation) Packs; Lot or serial number: 782186; Model or catalogue number: SNE30DB'XXX'
Affected products: DBS (Deep Brain Stimulation) Packs; Lot or serial number: 415650; Model or catalogue number: SNE30DB'XXX'
Affected products: DBS (Deep Brain Stimulation) Packs; Lot or serial number: 458996; Model or catalogue number: SNE30DB'XXX'
Affected products: DBS (Deep Brain Stimulation) Packs; Lot or serial number: 432014; Model or catalogue number: SNE30DB'XXX'
Affected products: General Ear, Nose And Throat (ENT) Packs; Lot or serial number: 438369; Model or catalogue number: SEN30EAOGG
Affected products: General Ear, Nose And Throat (ENT) Packs; Lot or serial number: 386142; Model or catalogue number: SEN30EAOGG
Affected products: General Ear, Nose And Throat (ENT) Packs; Lot or serial number: 450157; Model or catalogue number: SEN30EAOGH
Affected products: Sterile Ventriculoperitoneal (Strl VP) Children's Shunt Packs; Lot or serial number: 401223; Model or catalogue number: SNE30SHXXX
Affected products: Sterile Ventriculoperitoneal (Strl VP) Children's Shunt Packs; Lot or serial number: 387169; Model or catalogue number: SNE30SHHSO
Affected products: Basic Ear/Nose/Throat (ENT) Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30EN'XXX'
Affected products: Basic Ear/Nose/Throat (ENT) Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30EE'XXX'
Affected products: Basic Ear/Nose/Throat (ENT) Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30BE'XXX'
Affected products: Nose/Nasal Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30NSQED
Affected products: Nose/Nasal Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30BNCLA
Affected products: Nose/Nasal Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30NA'XXX'
Affected products: Nose/Nasal Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SEN30NO'XXX'
Affected products: Back Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SNE30BA'XXX'
Affected products: Orthopaedic Pack; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SOP30BKXXX
Affected products: Orthopaedic Pack; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SOP30ODXXX
Affected products: Discectomy Pack; Lot or serial number: 385340; Model or catalogue number: SNE30DLXXX
Affected products: Discectomy Pack; Lot or serial number: 426181; Model or catalogue number: SNE30DLXXX
Affected products: Discectomy Pack; Lot or serial number: 451228; Model or catalogue number: SNE30DLXXX
Affected products: Fat Graft Kit; Lot or serial number: 296591; Model or catalogue number: 21-47'XXX'
Affected products: Fat Graft Kit; Lot or serial number: 419327; Model or catalogue number: 21-47'XXX'
Affected products: Fat Graft Kit; Lot or serial number: 851712; Model or catalogue number: 21-47'XXX'
Affected products: Major Maxillary (Maxillo Majeur) Packs; Lot or serial number: 451206; Model or catalogue number: SBA30MFXXX
Affected products: Major Maxillary (Maxillo Majeur) Packs; Lot or serial number: 450008; Model or catalogue number: SBA30MFXXX
Affected products: Maj
The hazard
Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed® Neurological Sponges referenced. The recall is being issued due to unexpected variability of endotoxin levels on the products.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)