Quick summary
Quick summary: Medline Custom Procedure Packs - Compromised Breather Pouch. Date: 2024-10-07.
Public recall detail
Medline Custom Procedure Packs - Compromised Breather Pouch
2024-10-07
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Medline Custom Procedure Packs - Compromised Breather Pouch. Date: 2024-10-07.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandMedline Canada Corporation
ProductMedline Custom Procedure Packs - Compromised Breather Pouch
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-76287
Affected products
ProductEnsemble Abdo-Perineal
Lot23LBR317
ModelDYNJ38084B
Serial number23LBR317
DescriptionEnsemble Abdo-Perineal
ProductCataract Pack
Lot23KBB746
ModelDYNJ41861
Serial number23KBB746
DescriptionCataract Pack
ProductVag Rectal Pack Bh Lf
Lot23KBI386
ModelDYNJ41694B
Serial number23KBI386
DescriptionVag Rectal Pack Bh Lf
ProductPlastic Limb Sjhc-Lf
Lot23LBK468
ModelDYNJ84997
Serial number23LBK468
DescriptionPlastic Limb Sjhc-Lf
ProductPacemaker Tegh-Lf
Lot23KBB860
ModelDYNJ46745A
Serial number23KBB860
DescriptionPacemaker Tegh-Lf
ProductMajor Gyne Laparoscopy Shsc
Lot23LBN531
ModelDYNJ46774B
Serial number23LBN531
DescriptionMajor Gyne Laparoscopy Shsc
ProductPacemaker Set Up Pack
Lot23KBA116
ModelDYNJ40010B
Serial number23KBA116
DescriptionPacemaker Set Up Pack
ProductShunt Pack
Lot23KBB863
ModelDYNJ40040C
Serial number23KBB863
DescriptionShunt Pack
ProductAngiogram Lf
Lot23LBM850
ModelDYNJ41876B
Serial number23LBM850
DescriptionAngiogram Lf
ProductBreast Pk Tegh-Lf
Lot23LBO013 24ABF270
ModelDYNJ46717A
Serial number23LBO013 24ABF270
DescriptionBreast Pk Tegh-Lf
ProductEye Trays/Packs
Lot23KBB744
ModelDYNJ41769A
Serial number23KBB744
DescriptionEye Trays/Packs
ProductMajor Cysto Pack
Lot23KBN364
ModelDYNJ41871B
Serial number23KBN364
DescriptionMajor Cysto Pack
ProductEnsemble Pour Accouchement - Lf
Lot23LBM102
ModelDYNJ40933A
Serial number23LBM102
DescriptionEnsemble Pour Accouchement - Lf
ProductOral Surgery Pack Lf
Lot23KBF154
ModelDYNJ41862C
Serial number23KBF154
DescriptionOral Surgery Pack Lf
ProductPacemaker Pack Lf
Lot24ABA421
ModelDYNJ41925G
Serial number24ABA421
DescriptionPacemaker Pack Lf
ProductAbdominal Hysterectomy Tegh-Lf
Lot23LBP056
ModelDYNJ46730
Serial number23LBP056
DescriptionAbdominal Hysterectomy Tegh-Lf
ProductMajor Ophthalmic Pack
Lot24ABC781
ModelDYNJ40317
Serial number24ABC781
DescriptionMajor Ophthalmic Pack
ProductPlateau Catheterisme Cardiaque
Lot23LBG513
ModelHCT093J
Serial number23LBG513
DescriptionPlateau Catheterisme Cardiaque
ProductHernia Appendectomy Tegh-Lf
Lot23LBM976
ModelDYNJ46716
Serial number23LBM976
DescriptionHernia Appendectomy Tegh-Lf
ProductPlastic Hand Pack Tegh-Lf
Lot24ABG221
ModelDYNJ46739B
Serial number24ABG221
DescriptionPlastic Hand Pack Tegh-Lf
ProductEnsemble Surplus Lca- Lf
Lot23KBB893
ModelDYNJ48892C
Serial number23KBB893
DescriptionEnsemble Surplus Lca- Lf
ProductEnsemble Procedure Mineure
Lot23LBR333
ModelDYNJ38085C
Serial number23LBR333
DescriptionEnsemble Procedure Mineure
ProductVaginal Pack
Lot23KBD900
ModelDYNJ40037A
Serial number23KBD900
DescriptionVaginal Pack
ProductOrl Tympano Pack
Lot24ABB568
ModelDYNJ41674A
Serial number24ABB568
DescriptionOrl Tympano Pack
ProductCvl Insertion Kit- Lf
Lot23LBO732 24ABG354 23KBO606
ModelCDS984003A DYNJ48587A
Serial number23LBO732 24ABG354 23KBO606
DescriptionCvl Insertion Kit- Lf
ProductEnsemble Main/Poignet
Lot23LBM752
ModelDYNJ59375
Serial number23LBM752
DescriptionEnsemble Main/Poignet
ProductEnt Pack Cheo-Lf
Lot23LBV457
ModelDYNJ43538B
Serial number23LBV457
DescriptionEnt Pack Cheo-Lf
ProductGen Aurg - Minor-Lf
Lot24ABD039
ModelDYNJ45731A
Serial number24ABD039
DescriptionGen Aurg - Minor-Lf
ProductBreast Pack
Lot24ABD094
ModelDYNJ64376
Serial number24ABD094
DescriptionBreast Pack
ProductTurp Pack Lf
Lot24ABG266 23LBR757
ModelDYNJ41706C
Serial number24ABG266 23LBR757
DescriptionTurp Pack Lf
ProductFeet, Elbow, And Ankle Tegh-Lf
Lot23LBP194
ModelDYNJ46719B
Serial number23LBP194
DescriptionFeet, Elbow, And Ankle Tegh-Lf
ProductLft Hrt Cath Radial Access-Lf
Lot23LBL629
ModelDYNJ47667C
Serial number23LBL629
DescriptionLft Hrt Cath Radial Access-Lf
ProductGeneral Overbed Pack
Lot23LBM922 23KBF156
ModelDYNJ40045B
Serial number23LBM922 23KBF156
DescriptionGeneral Overbed Pack
ProductCysto Pack
Lot23LBK417 23LBP883 24ABG215
ModelDYNJ37171A DYNJ40010B
Serial number23LBK417 23LBP883 24ABG215
DescriptionCysto Pack
ProductApu Line Pack
Lot23KBD998
ModelDYNJ37171A
Serial number23KBD998
DescriptionApu Line Pack
ProductEp Pack
Lot23LBL628
ModelDYNJ40488
Serial number23LBL628
DescriptionEp Pack
Issue
Medline is issuing a recall of Medline custom procedure packs with compromised breather pouch. It has been determined that for certain packs the breather pouch seal may not be intact. The breather pouch is a sterile barrier and if the seals are not intact, then sterility of the pack and components inside can no longer be guaranteed. Recall start date: September 25, 2024
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use Health products - Medical devices - General and plastic surgery
CompaniesMedline Canada Corporation 5150 Spectrum Way, Mississauga, Ontario, Canada, L4W 5G2
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76287
Background{}
CompaniesMedline Canada Corporation 5150 Spectrum Way, Mississauga, Ontario, Canada, L4W 5G2
AudiencesHealthcare
Source updated2024-10-07
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
Frequently asked questions
Answers based on the official recall notice.
Product images
Official product images from Health Canada.
Starting...
Explore more
Related recalls
Similar recalls and safety notices.