Medline Custom Procedure Packs - Compromised Breather Pouch
Brand(s)
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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