Health product recall

Medline Custom Procedure Packs - Compromised Breather Pouch

Last updated

Summary

Product
Medline Custom Procedure Packs - Compromised Breather Pouch
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 catalogue number

Ensemble Abdo-Perineal

23LBR317

DYNJ38084B

Cataract Pack

23KBB746

DYNJ41861

Vag Rectal Pack Bh Lf

23KBI386

DYNJ41694B

Plastic Limb Sjhc-Lf

23LBK468

DYNJ84997

Pacemaker Tegh-Lf

23KBB860

DYNJ46745A

Major Gyne Laparoscopy Shsc

23LBN531

DYNJ46774B

Pacemaker Set Up Pack

23KBA116

DYNJ40010B

Shunt Pack

23KBB863

DYNJ40040C

Angiogram Lf

23LBM850

DYNJ41876B

Breast Pk Tegh-Lf

23LBO013
24ABF270

DYNJ46717A

Eye Trays/Packs

23KBB744

DYNJ41769A

Major Cysto Pack

23KBN364

DYNJ41871B

Ensemble Pour Accouchement - Lf

23LBM102

DYNJ40933A

Oral Surgery Pack Lf

23KBF154

DYNJ41862C

Pacemaker Pack Lf

24ABA421

DYNJ41925G

Abdominal Hysterectomy Tegh-Lf

23LBP056

DYNJ46730

Major Ophthalmic Pack

24ABC781

DYNJ40317

Plateau Catheterisme Cardiaque

23LBG513

HCT093J

Hernia Appendectomy Tegh-Lf

23LBM976

DYNJ46716

Plastic Hand Pack Tegh-Lf

24ABG221

DYNJ46739B

Ensemble Surplus Lca- Lf

23KBB893

DYNJ48892C

Ensemble Procedure Mineure

23LBR333

DYNJ38085C

Vaginal Pack

23KBD900

DYNJ40037A

Orl Tympano Pack

24ABB568

DYNJ41674A

Cvl Insertion Kit- Lf

23LBO732
24ABG354
23KBO606

CDS984003A
DYNJ48587A

Ensemble Main/Poignet

23LBM752

DYNJ59375

Ent Pack Cheo-Lf

23LBV457

DYNJ43538B

Gen Aurg - Minor-Lf

24ABD039

DYNJ45731A

Breast Pack

24ABD094

DYNJ64376

Turp Pack Lf

24ABG266
23LBR757

DYNJ41706C

Feet, Elbow, And Ankle Tegh-Lf

23LBP194

DYNJ46719B

Lft Hrt Cath Radial Access-Lf

23LBL629

DYNJ47667C

General Overbed Pack

23LBM922
23KBF156

DYNJ40045B

Cysto Pack

23LBK417
23LBP883
24ABG215

DYNJ37171A
DYNJ40010B

Apu Line Pack

23KBD998

DYNJ37171A

Ep Pack

23LBL628

DYNJ40488

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

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
Medline Canada Corporation
5150 Spectrum Way, Mississauga, Ontario, Canada, L4W 5G2
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76287

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