Cardinal Health - Presource® Kits Containing the Ritmed® Neurological Sponges
Last updated
Summary
Product
Cardinal Health - Presource® Kits Containing the Ritmed® Neurological Sponges
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Orthopaedic (Ortho) Spine Packs | 498644 | SOP30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 392650 | SOP30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 426499 | SOP30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 435000 | SOP30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 699880 | SNE30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 716193 | SNE30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 304629 | SNE30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 736240 | SNE30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 260104 | SNE30SP'XXX' |
| Orthopaedic (Ortho) Spine Packs | 724406 | SNE30SP'XXX' |
| Head and Neck Packs | 498623 | SEN30HN'XXX' |
| Head and Neck Packs | 478469 | SEN30HN'XXX' |
| Head and Neck Packs | 395935 | SEN30HN'XXX' |
| Head and Neck Packs | 380936 | SEN30HN'XXX' |
| Head and Neck Packs | 389664 | SEN30HN'XXX' |
| Vascular Pack | 403392 | SCV30VAFHS |
| Vascular Pack | 396012 | SCV30VAFHS |
| Burr Hole Packs | 406257 | SNE30BHXXX |
| Burr Hole Packs | 468614 | SNE30BHXXX |
| Burr Hole Packs | 483555 | SNE30BHXXX |
| Burr Hole Packs | 424226 | SNE30BHXXX |
| Burr Hole Packs | 386222 | SNE30BHXXX |
| Sinus Pack | More than 10 numbers, contact manufacturer. | SEN30EN'XXX' |
| Sinus Pack | More than 10 numbers, contact manufacturer. | SEN30SI'XXX' |
| Septoplasty Procedural Packs | More than 10 numbers, contact manufacturer. | SEN30NSXXX |
| Laminectomy Packs | 664226 | SNE30LMWTG |
| Laminectomy Packs | 694351 | SNE30LMWTG |
| Laminectomy Packs | 716192 | SNE30LMWTG |
| Laminectomy Packs | 506787 | SNE30LMWTF |
| Laminectomy Packs | 532491 | SNE30LMWTF |
| Laminectomy Packs | 582580 | SNE30LMWTF |
| Laminectomy Packs | 596894 | SNE30LMWTF |
| Laminectomy Packs | 411428 | SNE30LPYCP |
| Laminectomy Packs | 398293 | SNE30DL10C |
| Laminectomy Packs | 406259 | SNE30DL10C |
| Basic Plastic Packs | More than 10 numbers, contact manufacturer. | SBA30PL'XXX' |
| Transphenoidal Packs | 406264 | SEN30EN'XXX' |
| Transphenoidal Packs | 406264 | SNE30TR'XXX' |
| Craniotomy Packs | More than 10 numbers, contact manufacturer. | SNE30CNXXX |
| Craniotomy Packs | More than 10 numbers, contact manufacturer. | SNE30CRXXX |
| Craniotomy Packs | More than 10 numbers, contact manufacturer. | SNE30PCXXX |
| Breast Packs | 411410 | SBA30TR'XXX' |
| Breast Packs | 478443 | SBA30TR'XXX' |
| Eye Kit | 450173 | SEY30EYRVC |
| Eye Kit | 422397 | SEY30EYRVC |
| Eye Kit | 401238 | SEY30EYRVC |
| Ensemble Colonne | 460994 | SNE30SPXXX |
| Ensemble Colonne | 514728 | SNE30SPXXX |
| Ensemble Colonne | 503592 | SNE30SPXXX |
| Ensemble Colonne | 406167 | SNE30SPXXX |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPVHB |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPVHA |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30ENXXX |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30KH'XXX' |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30BS'XXX' |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30CR'XXX' |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30NP'XXX' |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30DB'XXX' |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30NE'XXX' |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30NUMGL |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30NUMGM |
| Lumbar Discoidectomy (Discoidectomie Lombaire) Packs | 398251 | SNE30LDXXX |
| Lumbar Discoidectomy (Discoidectomie Lombaire) Packs | 406260 | SNE30LDXXX |
| Lumbar Discoidectomy (Discoidectomie Lombaire) Packs | 495020 | SNE30LDXXX |
| Lumbar Discoidectomy (Discoidectomie Lombaire) Packs | 385385 | SOP30DLXXX |
| Lumbar Discoidectomy (Discoidectomie Lombaire) Packs | 461171 | SOP30DLXXX |
| Lumbar Discoidectomy (Discoidectomie Lombaire) Packs | 483853 | SOP30DLXXX |
| Lumbar Discoidectomy (Discoidectomie Lombaire) Packs | 497899 | SOP30DLXXX |
| Facial Surgery Packs | 426081 | SBA30MFXXX |
| DBS (Deep Brain Stimulation) Packs | 782186 | SNE30DB'XXX' |
| DBS (Deep Brain Stimulation) Packs | 415650 | SNE30DB'XXX' |
| DBS (Deep Brain Stimulation) Packs | 458996 | SNE30DB'XXX' |
| DBS (Deep Brain Stimulation) Packs | 432014 | SNE30DB'XXX' |
| General Ear, Nose And Throat (ENT) Packs | 438369 | SEN30EAOGG |
| General Ear, Nose And Throat (ENT) Packs | 386142 | SEN30EAOGG |
| General Ear, Nose And Throat (ENT) Packs | 450157 | SEN30EAOGH |
| Sterile Ventriculoperitoneal (Strl VP) Children's Shunt Packs | 401223 | SNE30SHXXX |
| Sterile Ventriculoperitoneal (Strl VP) Children's Shunt Packs | 387169 | SNE30SHHSO |
| Basic Ear/Nose/Throat (ENT) Packs | More than 10 numbers, contact manufacturer. | SEN30EN'XXX' |
| Basic Ear/Nose/Throat (ENT) Packs | More than 10 numbers, contact manufacturer. | SEN30EE'XXX' |
| Basic Ear/Nose/Throat (ENT) Packs | More than 10 numbers, contact manufacturer. | SEN30BE'XXX' |
| Nose/Nasal Packs | More than 10 numbers, contact manufacturer. | SEN30NSQED |
| Nose/Nasal Packs | More than 10 numbers, contact manufacturer. | SEN30BNCLA |
| Nose/Nasal Packs | More than 10 numbers, contact manufacturer. | SEN30NA'XXX' |
| Nose/Nasal Packs | More than 10 numbers, contact manufacturer. | SEN30NO'XXX' |
| Back Packs | More than 10 numbers, contact manufacturer. | SNE30BA'XXX' |
| Orthopaedic Pack | More than 10 numbers, contact manufacturer. | SOP30BKXXX |
| Orthopaedic Pack | More than 10 numbers, contact manufacturer. | SOP30ODXXX |
| Discectomy Pack | 385340 | SNE30DLXXX |
| Discectomy Pack | 426181 | SNE30DLXXX |
| Discectomy Pack | 451228 | SNE30DLXXX |
| Fat Graft Kit | 296591 | 21-47'XXX' |
| Fat Graft Kit | 419327 | 21-47'XXX' |
| Fat Graft Kit | 851712 | 21-47'XXX' |
| Major Maxillary (Maxillo Majeur) Packs | 451206 | SBA30MFXXX |
| Major Maxillary (Maxillo Majeur) Packs | 450008 | SBA30MFXXX |
| Major Maxillary (Maxillo Majeur) Packs | 466320 | SBA30MFXXX |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SFNOG |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30LPXXX |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPMNK |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPXXX |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPCHP |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPCHQ |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPMNJ |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30BAXXX |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30NE'XXX' |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30MMWTC |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPMNI |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30SPMNL |
| ENT Cervical Surgery Packs (Chirurgie Cervicale Packs) | 478401 | SEN30HN'XXX' |
| Ventriculoperitoneal (VP) Shunt Packs | 395945 | SNE30SHACO |
| Ventriculoperitoneal (VP) Shunt Packs | 406171 | SNE30SHACO |
| Ventriculoperitoneal (VP) Shunt Packs | 406261 | SNE30SHUHE |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - Orthopaedics
Companies
Cardinal Health 200, LLC Also Trading As Cardinal Health
3651 Birchwood Drive, Waukegan, Illinois, United States, 60085
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82377
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