Health product recall

Presource® kits containing Codman® Patties & Strips© components produced by Integra Lifesciences

Brand(s)
Cardinal Health 200, Llc Also Trading As Cardinal Health
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.

SOP30BKIW1
SOP30BKIW2
SOP30BKIW3
SOP30BKIW4
SOP30BKIWL
SOP30BKIWM
SOP30BKIWN

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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