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
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Ear Packs | 348735 | SEN30EAMUH |
| Neurology Packs | More than 10 numbers, contact manufacturer. | SNE30NP103 SNE30NP10E SNE30NP10F SNE30NEPM5 SNE30NP10B SNE30NP10C SNE30NEPMF SNE30NP10D SNE30NEPM6 SNE30NEPM7 SNE30NEPMG SNE30NEPM4 |
| Sinus Pack | More than 10 numbers, contact manufacturer. | SEN30SISUA SEN30ENSUA SEN30ENSU1 SEN30ENUAD |
| Nasal Packs | 330121 339998 309455 416502 435035 382379 356142 491070 457445 | SEN30NSQE4 SEN30NSQEC |
| Nose/Nasal Packs | More than 10 numbers, contact manufacturer. | SEN30NARO1 SEN30NOQGI SEN30NOQG7 SEN30NOQG8 SEN30NAKGD SEN30BNMHA SEN30NAROH SEN30NSQED SEN30NARO2 SEN30NARO3 SEN30NSQE5 SEN30NSQE6 |
| Orthopaedic (Ortho) Spine Packs | More than 10 numbers, contact manufacturer. | SOP30SPT19 SOP30SPTH6 SOP30SPT11 SOP30SPT13 SOP30SPTH9 SOP30SPT16 SOP30SPT18 SOP30SPT20 SOP30SPTHG SOP30SPTH2 SOP30SPT17 SOP30SPTH8 SOP30SPT14 SOP30SPT21 SOP30SPTHF SOP30SPTHH SOP30SPT10 SOP30SPT12 SOP30SPT15 SOP30SPTH3 SOP30SPTH4 SOP30SPTH5 SOP30SPTH7 |
| Spinal Packs | More than 10 numbers, contact manufacturer. | SNE30NEPMI SNE30NEPM8 SNE30NEPM9 SNE30NEPMH |
| Basic Ear/Nose/Throat (ENT) Packs | More than 10 numbers, contact manufacturer. | SEN30ENCSA SEN30ENCS1 SEN30ENUA3 SEN30ENUAE |
| Transphenoidal Packs | More than 10 numbers, contact manufacturer. | SNE30TRWTD SNE30TRWTE SNE30TRWT4 SNE30TRWT3 SNE30TRWT5 SNE30TRWT7 SNE30TRWTF SNE30TRWTG SNE30TRWT2 SNE30TRWT6 SEN30ENQEC SEN30ENQED SEN30ENQEE SEN30ENQEF |
| Ear Kits | More than 10 numbers, contact manufacturer. | PE30EAGTB PE30EAGT6 PE30EAGT8 PE30EAGTC PE30EAGTD PE30EAGT7 PE30EAGT9 |
| Craniotomy Packs | More than 10 numbers, contact manufacturer. | SNE30CNPM4 SNE30CNPMH SNE30CNWT3 SNE30CRCCL SNE30CRCL7 SNE30CRG11 SNE30CRGM3 SNE30CRRO1 SNE30CRT10 SNE30CRTH4 SNE30CRVC6 SNE30CNPM6 SNE30CRCLS SNE30CRGMJ SNE30CRGMK SNE30CRKGM SNE30CRRO4 SNE30CRROK SNE30CRT16 SNE30CRT17 SNE30CRT21 SNE30CRTH8 SNE30CNWTC SNE30CRG10 SNE30CRG12 SNE30CRGM9 SNE30CRT22 SNE30CRTH9 SNE30CRTHJ SNE30CRVC8 SNE30CRVCO SNE30CRVCQ SNE30CRCC7 SNE30CRCC8 SNE30CRCCK SNE30CRCLT SNE30CRGM7 SNE30CRKG7 SNE30CRT11 SNE30CRTH5 SNE30CRVCP SNE30CNPM2 SNE30CNPM3 SNE30CNWTD SNE30CRCL6 SNE30CRGM5 SNE30CRKG9 SNE30CRKGL SNE30CRRO5 SNE30CRROL SNE30CRTH6 SNE30CRTH7 SNE30CNPMJ SNE30CNWTB SNE30CRG13 SNE30CRRO2 SNE30CRT20 SNE30CRVC4 SNE30CRVC5 SNE30CRVC7 SNE30CNPM7 SNE30CNWT2 SNE30CNWT4 SNE30CNWT5 SNE30CNWT6 SNE30CRCCM SNE30CRCL8 SNE30CRCLR SNE30CRGM6 SNE30CRKG5 SNE30CRKG6 SNE30CRKG8 SNE30CRT13 SNE30CRT14 SNE30CRT18 SNE30CRT19 SNE30CNPM5 SNE30CNPMI SNE30CNWT1 SNE30CRCC6 SNE30CRGM4 SNE30CRGM8 SNE30CRGMI SNE30CRRO3 SNE30CRT12 SNE30CRT15 SNE30CRTHK SNE30CRTHL SNE30CRVC3 SNE30CNQE2 SNE30CNQE3 SNE30CNQE4 SNE30CNQE5 SNE30CNQE6 SNE30CNQE7 SNE30CNQED SNE30CNQEF SNE30CNQEG SNE30CNQEH SNE30CRIW3 SNE30CRIWU SNE30CRIWV |
| Basic Middle Ear Packs (Ensemble Basic Middle Ear) | 538143 | SEN30MEJGN |
| Ensemble Colonne | More than 10 numbers, contact manufacturer. | SNE30SPCL4 SNE30SPCL2 SNE30SPCL5 SNE30SPCL7 SNE30SPCL8 SNE30SPCLM SNE30SPCL3 SNE30SPCL6 SNE30SPCLK SNE30SPCLL |
| Functional Endoscopic Sinus Surgery (FESS) Packs | More than 10 numbers, contact manufacturer. | SEN30ENPO3 SEN30FEMHA SEN30ENPO4 SEN30ENPO2 SEN30ENPOD SEN30FEOTE SEN30ENPO6 SEN30FEOTD SEN30ENPO8 SEN30ENPOC SEN30ENPO5 SEN30ENPO7 SEN30FEOT5 SEN30FEOT6 SEN30FEOT7 |
| Discectomy Pack | More than 10 numbers, contact manufacturer. | SNE30DLCL1 SNE30DLCLN SNE30DLCL2 |
| Orthopaedic Pack | More than 10 numbers, contact manufacturer. | SOP30BKIW2 SOP30BKIW3 SOP30BKIW4 SOP30BKIW1 SOP30BKIWN SOP30BKIWL SOP30BKIWM |
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 and determined that customers have received Presource® kits containing affected Codman® Patties & Strips© component produced by Integra Lifesciences. Based on the results of that completed assessment, Cardinal Health is issuing a recall for Presource® kits containing Codman® Patties & Strips© components produced by Integra Lifesciences.
Recall Start Date: November 12, 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 - 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
Recall class
Type II
Identification number
RA-76553
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