Health product recall

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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