Presource® kits containing Codman® Patties & Strips© components produced by Integra Lifesciences
Last updated
Summary
Product
Presource® kits containing Codman® Patties & Strips© components produced by Integra Lifesciences
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Cervical Disc Surgery | More than 10 numbers, contact manufacturer. | SNE30HNCLM SNE30HNCLK SNE30HNCLL SNE30HNVOF |
| Vascular Pack (Device Licence #532) | More than 10 numbers, contact manufacturer. | SCV30VAF10 SCV30VAFHQ SCV30VAFHS SCV30VAFH5 SCV30VAFH8 SCV30VAFH7 SCV30VAFHR SCV30VAFH4 SCV30VAFH6 SCV30VAFH9 SCV30VAFHP |
| Back Packs (Device Licence #8893) | More than 10 numbers, contact manufacturer. | SOP30BASB6 SOP30BASBG SOP30BASBE SOP30BAS11 SOP30BASB5 SOP30BASBC SOP30BASBD SOP30BASB7 SOP30BASB8 SNE30BASBN SOP30BASB9 SOP30BASBF SOP30BAS10 |
| Ear Packs | More than 10 numbers, contact manufacturer. | SEN30MYHM6 SEN30MYHMR SEN30MYHM3 SEN30MYHM5 SEN30MYHM7 SEN30MYHM9 SEN30MYH10 SEN30MYH14 SEN30MYH15 SEN30MYHM8 SEN30MYHMT SEN30MYHM4 SEN30MYH11 SEN30MYH12 SEN30MYH13 SEN30MYHMS |
| Head And Neck Packs (Device Licence #6766) | More than 10 numbers, contact manufacturer. | SEN30HNCH4 SEN30HNCHK SEN30HNCH3 SNE30HNVOE SEN30HNCH6 SEN30HNCHI SEN30HNCH5 SEN30HNCHH SEN30HNCH7 SEN30HNCHJ |
| Head And Neck Packs (Device Licence #7279) | More than 10 numbers, contact manufacturer. | SEN30HNCH4 SEN30HNCHK SEN30HNCH3 SNE30HNVOE SEN30HNCH6 SEN30HNCHI SEN30HNCH5 SEN30HNCHH SEN30HNCH7 SEN30HNCHJ |
| Burr Hole Packs | More than 10 numbers, contact manufacturer. | SNE30BHRGC SNE30BHSD3 SNE30BHSD4 SNE30BHWTC SNE30BHSD1 SNE30BHSD2 SNE30BHWT5 SNE30BHWT2 SNE30BHWTB SNE30BHSDH SNE30BHRGB SNE30BHSD5 SNE30BHWT3 SNE30BHSDF SNE30BHSDG SNE30BHWT4 SNE30BHWTD |
| General Ear, Nose And Throat (ENT) Packs | More than 10 numbers, contact manufacturer. | SEN30EAOG3 SEN30EAOG2 SEN30EAOG4 SEN30EAOG1 SEN30EAOGF SEN30EAOGG SEN30EAOGD SEN30EAOGE |
| Facial Surgery Packs | More than 10 numbers, contact manufacturer. | SBA30MFOCC SBA30MFOCA SBA30MFOCD SBA30MFOCB |
| Functional Endoscopic Sinus Surgery (FESS) Packs | More than 10 numbers, contact manufacturer. | SEN30FEGM4 SEN30FEOR6 SEN30FEGM5 SEN30FEOR4 SEN30FEORB SEN30SSQE1 SEN30SSQE2 SEN30FEOR5 SEN30FEGMG SEN30SSQEJ SEN30FEGHG SEN30FEGMH |
| Nose/Nasal Packs | More than 10 numbers, contact manufacturer. | SEN30NAHRG SEN30ONSL3 SEN30NSDU1 SEN30NSDUD SEN30NSDUE SEN30ONSL1 SEN30NAHR3 SEN30ONSL2 SEN30ONSLA SEN30NAHR5 SEN30NSDUF SEN30ONSL4 SEN30NAHR4 SEN30NAHR6 SEN30NSDUC |
| Ventriculoperitoneal (VP) Shunt Packs | More than 10 numbers, contact manufacturer. | SNE30SHRHJ SNE30SHUH8 SNE30VSWTB SNE30VSWTC SNE30VSWTD SNE30SHRH2 SNE30SHRH3 SNE30SHUH6 SNE30SHUH7 SNE30SHUHD SNE30SHACO SNE30SHU10 SNE30SHUH3 SNE30SHRHI SNE30SHUH9 SNE30VSWT1 SNE30VSWT2 SNE30VSWT3 SNE30SHACL SNE30SHRH4 SNE30SHUHE SNE30VSWT4 SNE30SHACK SNE30SHUH4 SNE30SHACN SNE30SHUH2 |
| Transphenoidal Packs | More than 10 numbers, contact manufacturer. | SNE30TRMU4 SNE30TRMUE SNE30TRMU2 SNE30TRMUH SNE30TRMU3 SNE30TRMUF SEN30TRTHA SNE30TRMUG SNE30TRMU5 |
| Laminectomy Packs | More than 10 numbers, contact manufacturer. | SNE30LMWT4 SNE30LMWT5 SNE30DL102 SNE30DL10C SNE30LMWT3 SNE30LPYC6 SNE30LPYC7 SNE30LMWT1 SNE30LPYCO SNE30DL10B SNE30DLRHZ SNE30LMWTC SNE30LMWTE SNE30LPYC5 SNE30DL10A SNE30LMWT6 SNE30LMWTB SNE30LMWTD SNE30LPYCP SNE30DL101 SNE30LMWT2 SNE30LMWT7 |
| Orthopaedic (Ortho) Spine Packs | More than 10 numbers, contact manufacturer. | SOP30SPBC2 SOP30SPBCB SOP30SPBCC SOP30SPNL1 SOP30SPBC3 SOP30SPBC4 SOP30SPNLE SNE30NEF15 SOP30SPBC5 |
| Sterile Ventriculoperitoneal (Strl VP) Children's Shunt Packs | More than 10 numbers, contact manufacturer. | SNE30SHHS3 SNE30SHHSO SNE30SHHSN SNE30SHHS5 SNE30SHHS6 SNE30SHHSM SNE30SHHS4 SNE30SHHS2 |
| Back Packs (Device Licence #72938) | More than 10 numbers, contact manufacturer. | SOP30BASB6 SOP30BASBG SOP30BASBE SOP30BAS11 SOP30BASB5 SOP30BASBC SOP30BASBD SOP30BASB7 SOP30BASB8 SNE30BASBN SOP30BASB9 SOP30BASBF SOP30BAS10 |
| Discectomy Pack | More than 10 numbers, contact manufacturer. | SNE30DLCLM SNE30DLCLL SNE30DLVOH |
| Sinus Pack | More than 10 numbers, contact manufacturer. | SEN30SISLM SEN30SISP3 SEN30SISP4 SEN30SISP7 SEN30SISP5 SEN30SISP8 SEN30SISLN SEN30SISL2 SEN30SISLO SEN30SISL3 SEN30SISP6 SEN30SISL4 SEN30SISPC SEN30SISL1 |
| Septoplasty Procedural Packs | More than 10 numbers, contact manufacturer. | SEN30RHORB SEN30RHOR7 SEN30RHOR6 SEN30RHORC |
| Head And Neck Packs (Device Licence #72941) | More than 10 numbers, contact manufacturer. | SEN30HNCH4 SEN30HNCHK SEN30HNCH3 SNE30HNVOE SEN30HNCH6 SEN30HNCHI SEN30HNCH5 SEN30HNCHH SEN30HNCH7 SEN30HNCHJ |
| Eye Kit | More than 10 numbers, contact manufacturer. | SEY30EYRVC SEY30EYRVA SEY30EYRVB |
| Craniotomy Packs | More than 10 numbers, contact manufacturer. | SNE30CRU42 SNE30PCU14 SNE30CRMN2 SNE30CRSBP SNE30CRSBS SNE30CRSDH SNE30CRU22 SNE30CRU32 SNE30CRU43 SNE30PCC14 SNE30PCUA9 SEN30CRMNH SNE30CNKG4 SNE30CRGMK SNE30CRMN1 SNE30CRSD4 SNE30CRU16 SNE30CRU19 SNE30CRU21 SNE30CRU35 SNE30CRU37 SNE30PCC19 SNE30PCCHJ SNE30PCCHK SNE30PCCHL SNE30PCU10 SNE30PCU16 SNE30PCU18 SNE30PCUAM SNE30CNKG3 SNE30CNVG5 SNE30CRACR SNE30CRSD6 SNE30CRU17 SNE30CRU23 SNE30CRU28 SNE30CRU31 SNE30CRU38 SNE30CRU39 SNE30CRU40 SNE30PCCH8 SNE30PCCHM SNE30PCUAK SNE30CNKGP SNE30CRACO SNE30CRSBR SNE30CRU24 SNE30CRU29 SNE30CRUHT SNE30PCC11 SNE30PCU11 SNE30PCU12 SNE30PCU17 SNE30CRSB7 SNE30CRSD2 SNE30CRSD5 SNE30CRSDI SNE30CRU18 SNE30CRU41 SNE30CRUH5 SNE30CRUHS SNE30PCC12 SNE30PCC21 SNE30PCU15 SNE30PCUA8 SNE30PCUAN SNE30CNKGQ SNE30CNVG4 SNE30CNVG6 SNE30CNVG7 SNE30CNVGC SNE30CNVGE SNE30CRAC2 SNE30CRAC3 SNE30CRU27 SNE30CRU30 SNE30CRUAY SNE30CRUAZ SNE30CRUH6 SNE30PCC10 SNE30PCC17 SNE30PCC18 SNE30PCU13 SNE30CNKG2 SNE30CNKG5 SNE30CNKGO SNE30CNVGB SNE30CRMNA SNE30CRU20 SNE30CRU25 SNE30CRU33 SNE30CRU34 SNE30CRU36 SNE30CRUH8 SNE30CRUH9 SNE30CRUHU SNE30PCC13 SNE30PCC15 SNE30PCC16 SNE30PCC20 SNE30PCCH9 SNE30PCUA7 SNE30PCUAL SNE30CNVG2 SNE30CNVG3 SNE30CNVGD SNE30CRACQ SNE30CRSB8 SNE30CRSBO SNE30CRSD3 SNE30CRU26 |
| Basic Ear/Nose/Throat (ENT) Packs | More than 10 numbers, contact manufacturer. | SEN30ENFHM SEN30BEMSA SEN30ENFHN |
| Vascular Pack (Device Licence #72937) | More than 10 numbers, contact manufacturer. | SCV30VAF10 SCV30VAFHQ SCV30VAFHS SCV30VAFH5 SCV30VAFH8 SCV30VAFH7 SCV30VAFHR SCV30VAFH4 SCV30VAFH6 SCV30VAFH9 SCV30VAFHP |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30CRFT7 SNE30ENFH3 SNE30ENMHA SNE30NEUHF SNE30CRFT8 SNE30ENFHH SNE30KHVO1 SNE30NEFHF SNE30NEUH4 SNE30NEUHE SNE30NPCH6 SNE30NPGH5 SNE30NPGHU SNE30CRFT9 SNE30ENFH2 SNE30NEUH5 SNE30NPCH4 SNE30NPGH6 SNE30KHVOE SNE30NEUH3 SNE30NPCH5 SNE30NPCHD SNE30NPGHS SNE30BSCNL SNE30CRJGX SNE30NEUH1 SNE30NPGHT SNE30NEFHE SNE30NPGH4 SNE30CRACP SNE30CRSBQ SNE30KHVOF SNE30NEUH6 SNE30CRFTH SNE30ENMHB SNE30NEUH2 SNE30NPCHE SNE30NPCHF SNE30SHACM |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30ACWT2 SNE30ACWT3 SNE30ACWTE SNE30BASB2 SNE30BASB4 SNE30LPWTC SNE30SFNO2 SNE30SPCHO SOP30SPVHJ SNE30BASB5 SNE30LPWT5 SNE30LPWT6 SNE30LPWT7 SNE30MDWT4 SNE30SFNOG SNE30SPCH4 SNE30SPCHL SNE30SPNLB SNE30BASB3 SNE30BASBP SNE30LPWT3 SNE30LPWT4 SNE30LPWTD SNE30NEFHO SNE30SFNO1 SNE30SPVHA SOP30SPVH2 SOP30SPVH3 SNE30ACWTC SNE30ACWTF SNE30BASB6 SNE30SPCHP SNE30BASBO SNE30BASBR SNE30LPWT1 SNE30LPWTB SNE30MMWT2 SNE30MMWT3 SOP30SPVH1 SNE30MDWT2 SNE30MMWT1 SNE30MMWTC SNE30SPCH1 SNE30SPCHN SNE30ACWTD SNE30BASBQ SNE30MDWT1 SNE30MDWTC SNE30MMWTB SNE30SPCH2 SNE30SPCHK SNE30ACWT4 SNE30ACWT5 SNE30ACWTB SNE30LPWT2 SNE30LPWTE SNE30MDWT3 SNE30MDWTB SNE30SFNOF SNE30SPCH3 |
| DBS (Deep Brain Stimulation) Packs | More than 10 numbers, contact manufacturer. | SNE30DBWT9 SNE30DBWT8 SNE30DBWTB SNE30DBWTC SNE30DBWT5 SNE30DBWT7 SNE30DBWT6 SNE30DBWT4 |
| Basic Middle Ear Packs | More than 10 numbers, contact manufacturer. | SEN30TYHMT SEN30TYHM2 SEN30TYHMU |
| Lumbar Discoidectomy Packs | More than 10 numbers, contact manufacturer. | SOP30DLCBC SOP30DLCBD SOP30DLCBB |
| Lumbar Discoidectomy Packs | More than 10 numbers, contact manufacturer. | SNE30LDSC3 SNE30LDU10 SNE30LDSCD SNE30LDSCE SNE30LDUH7 SNE30LDUHL SNE30LDUHM SNE30LDUH6 SOP30DLGM4 SNE30LDSC4 SOP30DLGM7 SOP30DLGM8 SNE30LDUH4 SNE30LDUH9 SOP30DLGMM SNE30LDSC1 SNE30LDSCB SOP30DLGM5 SOP30DLGML SNE30LDSC2 SNE30LDSCC SNE30LDUH5 SNE30LDUH8 SOP30DLGM3 SOP30DLGM6 |
Issue
Cardinal Health received communication from Integra Lifesciences, which recommended an assessment be completed for bulk-non-sterile surgical strips and patties due to potential endotoxin contamination. Presource® has completed its assessment related to this communication and determined customers may have received Presource® kits containing affected Codman® Patties & Strips© components produced by Integra Lifesciences. Based on the results of that completed assessment, Cardinal Health is issuing a field action event to over label Presource® kits containing affected Codman® Patties & Strips© components produced by Integra Lifesciences.
Recall Start Date: November 11, 2024
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 - Cardiovascular
Health products - Medical devices - General and plastic surgery
Companies
Cardinal Health 200, Llc Also Trading As Cardinal Health
3651 Birchwood Drive, Waukegan, Illinois, United States, 60085
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-76556
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