Presource® kits containing Codman® Patties & Strips© components produced by Integra Lifesciences
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Cervical Disc Surgery |
More than 10 numbers, contact manufacturer. |
SNE30HNCLM |
Vascular Pack (Device Licence #532) |
More than 10 numbers, contact manufacturer. |
SCV30VAF10 |
Back Packs (Device Licence #8893) |
More than 10 numbers, contact manufacturer. |
SOP30BASB6 |
Ear Packs |
More than 10 numbers, contact manufacturer. |
SEN30MYHM6 |
Head And Neck Packs (Device Licence #6766) |
More than 10 numbers, contact manufacturer. |
SEN30HNCH4 |
Head And Neck Packs (Device Licence #7279) |
More than 10 numbers, contact manufacturer. |
SEN30HNCH4 |
Burr Hole Packs |
More than 10 numbers, contact manufacturer. |
SNE30BHRGC |
General Ear, Nose And Throat (ENT) Packs |
More than 10 numbers, contact manufacturer. |
SEN30EAOG3 |
Facial Surgery Packs |
More than 10 numbers, contact manufacturer. |
SBA30MFOCC |
Functional Endoscopic Sinus Surgery (FESS) Packs |
More than 10 numbers, contact manufacturer. |
SEN30FEGM4 |
Nose/Nasal Packs |
More than 10 numbers, contact manufacturer. |
SEN30NAHRG |
Ventriculoperitoneal (VP) Shunt Packs |
More than 10 numbers, contact manufacturer. |
SNE30SHRHJ |
Transphenoidal Packs |
More than 10 numbers, contact manufacturer. |
SNE30TRMU4 |
Laminectomy Packs |
More than 10 numbers, contact manufacturer. |
SNE30LMWT4 |
Orthopaedic (Ortho) Spine Packs |
More than 10 numbers, contact manufacturer. |
SOP30SPBC2 |
Sterile Ventriculoperitoneal (Strl VP) Children's Shunt Packs |
More than 10 numbers, contact manufacturer. |
SNE30SHHS3 |
Back Packs (Device Licence #72938) |
More than 10 numbers, contact manufacturer. |
SOP30BASB6 |
Discectomy Pack |
More than 10 numbers, contact manufacturer. |
SNE30DLCLM |
Sinus Pack |
More than 10 numbers, contact manufacturer. |
SEN30SISLM |
Septoplasty Procedural Packs |
More than 10 numbers, contact manufacturer. |
SEN30RHORB |
Head And Neck Packs (Device Licence #72941) |
More than 10 numbers, contact manufacturer. |
SEN30HNCH4 |
Eye Kit |
More than 10 numbers, contact manufacturer. |
SEY30EYRVC |
Craniotomy Packs |
More than 10 numbers, contact manufacturer. |
SNE30CRU42 |
Basic Ear/Nose/Throat (ENT) Packs |
More than 10 numbers, contact manufacturer. |
SEN30ENFHM |
Vascular Pack (Device Licence #72937) |
More than 10 numbers, contact manufacturer. |
SCV30VAF10 |
Neurology Packs |
More than 10 numbers, contact manufacturer. |
SNE30CRFT7 |
Spinal Packs |
More than 10 numbers, contact manufacturer. |
SNE30ACWT2 |
DBS (Deep Brain Stimulation) Packs |
More than 10 numbers, contact manufacturer. |
SNE30DBWT9 |
Basic Middle Ear Packs |
More than 10 numbers, contact manufacturer. |
SEN30TYHMT |
Lumbar Discoidectomy Packs |
More than 10 numbers, contact manufacturer. |
SOP30DLCBC |
Lumbar Discoidectomy Packs |
More than 10 numbers, contact manufacturer. |
SNE30LDSC3 |
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
Cardinal Health 200, Llc Also Trading As Cardinal Health
3651 Birchwood Drive, Waukegan, Illinois, United States, 60085
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