Health Products

Medline Neuro Sponges

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use, Health products - Medical devices - Ear, nose and throat, Health products - Medical devices - Cardiovascular, Health products - Medical devices - General and plastic surgery
Product: Medline Neuro Sponges
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Neuro PacksAll lots.CDS984000D
Neuro PacksAll lots.DYNJ37190C
Neuro PacksAll lots.DYNJ41856B
Neuro PacksAll lots.DYNJ41856C
Neuro PacksAll lots.DYNJ41857C
Neuro PacksAll lots.DYNJ41857D
Neuro PacksAll lots.DYNJ41858B
Neuro PacksAll lots.DYNJ41858C
Neuro PacksAll lots.DYNJ41859B
Neuro PacksAll lots.DYNJ41859C
Neuro PacksAll lots.DYNJ47568B
Neuro PacksAll lots.DYNJ47575B
Neuro PacksAll lots.DYNJ47575C
Neuro PacksAll lots.DYNJ47575D
Neuro PacksAll lots.DYNJ48508B
Neuro PacksAll lots.DYNJ52381
Neuro PacksAll lots.DYNJ52812A
Neuro PacksAll lots.DYNJ65730A
Neuro PacksAll lots.DYNJT3690
Neuro PacksAll lots.DYNJT3694
Neuro PacksAll lots.DYNJ39996F
Neuro PacksAll lots.DYNJ39997F
Neuro PacksAll lots.DYNJ41832C
Neuro PacksAll lots.DYNJ46769B
Neuro PacksAll lots.DYNJ46769C
Neuro PacksAll lots.DYNJ39989G
ENT TraysAll lots.DYNJ41676A
ENT TraysAll lots.DYNJ41676B
ENT TraysAll lots.DYNJ41922C
ENT TraysAll lots.DYNJ41922D
ENT TraysAll lots.DYNJ41923D
ENT TraysAll lots.DYNJ49788B
ENT TraysAll lots.DYNJ56847A
ENT TraysAll lots.DYNJ56847B
ENT TraysAll lots.DYNJ62803
ENT TraysAll lots.DYNJ69558
ENT TraysAll lots.DYNJ69558A
ENT TraysAll lots.DYNJ69829
ENT TraysAll lots.DYNJ82667
ENT TraysAll lots.DYNJ84975
ENT TraysAll lots.DYNJ87705
ENT TraysAll lots.DYNJ87708
ENT TraysAll lots.DYNJ903834B
ENT TraysAll lots.DYNJ905543G
ENT TraysAll lots.DYNJT3183
General Surgical TrayAll lots.DYNJ59740A
General Surgical TrayAll lots.DYNJ908680
General Surgical TrayAll lots.DYNJ908680A
General Surgical TrayAll lots.DYNJ908680B
General Surgical TrayAll lots.DYNJ908680C
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJ41666A
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJ41666B
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJ41787G
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJ41787I
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJ41787J
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJ41831C
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJ41833C
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJ46759F
Custom Orthopaedic Procedure Kit/TrayAll lots.DYNJT3691A
Custom Oral\Dental Procedure Kit\TrayAll lots.DYNJ41862C
Custom General Surgery Procedure Kit/TrayAll lots.DYNJ42670A
Custom Cardiovascular Procedure Kit/TrayAll lots.DYNJ88249
Custom Urology Procedure Kit/TrayAll lots.DYNJT4030
Neurosurgery Custom Procedure PacksAll lots.DYNJ37190D
Neurosurgery Custom Procedure PacksAll lots.DYNJ37190F
Neurosurgery Custom Procedure PacksAll lots.DYNJ40040C
Neurosurgery Custom Procedure PacksAll lots.DYNJ40042C
Neurosurgery Custom Procedure PacksAll lots.DYNJ41831D
Neurosurgery Custom Procedure PacksAll lots.DYNJ41831F
Neurosurgery Custom Procedure PacksAll lots.DYNJ41832D
Neurosurgery Custom Procedure PacksAll lots.DYNJ41832F
Neurosurgery Custom Procedure PacksAll lots.DYNJ49548A
Neurosurgery Custom Procedure PacksAll lots.DYNJ87603
Neurosurgery Custom Procedure PacksAll lots.DYNJ87715
Neurosurgery Custom Procedure PacksAll lots.DYNJ903841D
Neurosurgery Custom Procedure PacksAll lots.DYNJS1002
General Surgery Custom Procedure PacksAll lots.DYNJ46781B
Composite Neck Dissec SHSC-LFAll lots.DYNJ46776D

Issue

Medline kits containing neuro sponges are being recalled due to a potential out-of-specification for endotoxin for the neuro sponges. Elevated endotoxin levels may present potential health risks requiring medical or surgical intervention. The likelihood of adverse health consequences is considered remote. However, customers should discard the recalled component prior to using the kit.

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