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Medline custom procedure packs - compromised breather pouch

Official notice

7 Oct 2024

Last checked

7 Oct 2024

Medium riskHealth Canada

An official Health Canada notice concerns Medline custom procedure packs - compromised breather pouch. 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 Published 2024-10-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76287

Official notice

2024-10-07

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76287

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Affected products

Product 1

Affected products - Ensemble Abdo-Perineal, Lot or serial number - 23LBR317, Model or catalogue number - DYNJ38084B

Product 2

Affected products - Cataract Pack, Lot or serial number - 23KBB746, Model or catalogue number - DYNJ41861

Product 3

Affected products - Vag Rectal Pack Bh Lf, Lot or serial number - 23KBI386, Model or catalogue number - DYNJ41694B

Product 4

Affected products - Plastic Limb Sjhc-Lf, Lot or serial number - 23LBK468, Model or catalogue number - DYNJ84997

Product 5

Affected products - Pacemaker Tegh-Lf, Lot or serial number - 23KBB860, Model or catalogue number - DYNJ46745A

Product 6

Affected products - Major Gyne Laparoscopy Shsc, Lot or serial number - 23LBN531, Model or catalogue number - DYNJ46774B

Product 7

Affected products - Pacemaker Set Up Pack, Lot or serial number - 23KBA116, Model or catalogue number - DYNJ40010B

Product 8

Affected products - Shunt Pack, Lot or serial number - 23KBB863, Model or catalogue number - DYNJ40040C

Product 9

Affected products - Angiogram Lf, Lot or serial number - 23LBM850, Model or catalogue number - DYNJ41876B

Product 10

Affected products - Breast Pk Tegh-Lf, Lot or serial number - 23LBO013 24ABF270, Model or catalogue number - DYNJ46717A

Product 11

Affected products - Eye Trays/Packs, Lot or serial number - 23KBB744, Model or catalogue number - DYNJ41769A

Product 12

Affected products - Major Cysto Pack, Lot or serial number - 23KBN364, Model or catalogue number - DYNJ41871B

Product 13

Affected products - Ensemble Pour Accouchement - Lf, Lot or serial number - 23LBM102, Model or catalogue number - DYNJ40933A

Product 14

Affected products - Oral Surgery Pack Lf, Lot or serial number - 23KBF154, Model or catalogue number - DYNJ41862C

Product 15

Affected products - Pacemaker Pack Lf, Lot or serial number - 24ABA421, Model or catalogue number - DYNJ41925G

Product 16

Affected products - Abdominal Hysterectomy Tegh-Lf, Lot or serial number - 23LBP056, Model or catalogue number - DYNJ46730

Product 17

Affected products - Major Ophthalmic Pack, Lot or serial number - 24ABC781, Model or catalogue number - DYNJ40317

Product 18

Affected products - Plateau Catheterisme Cardiaque, Lot or serial number - 23LBG513, Model or catalogue number - HCT093J

Product 19

Affected products - Hernia Appendectomy Tegh-Lf, Lot or serial number - 23LBM976, Model or catalogue number - DYNJ46716

Product 20

Affected products - Plastic Hand Pack Tegh-Lf, Lot or serial number - 24ABG221, Model or catalogue number - DYNJ46739B

Product 21

Affected products - Ensemble Surplus Lca- Lf, Lot or serial number - 23KBB893, Model or catalogue number - DYNJ48892C

Product 22

Affected products - Ensemble Procedure Mineure, Lot or serial number - 23LBR333, Model or catalogue number - DYNJ38085C

Product 23

Affected products - Vaginal Pack, Lot or serial number - 23KBD900, Model or catalogue number - DYNJ40037A

Product 24

Affected products - Orl Tympano Pack, Lot or serial number - 24ABB568, Model or catalogue number - DYNJ41674A

Product 25

Affected products - Cvl Insertion Kit- Lf, Lot or serial number - 23LBO732 24ABG354 23KBO606, Model or catalogue number - CDS984003A DYNJ48587A

Product 26

Affected products - Ensemble Main/Poignet, Lot or serial number - 23LBM752, Model or catalogue number - DYNJ59375

Product 27

Affected products - Ent Pack Cheo-Lf, Lot or serial number - 23LBV457, Model or catalogue number - DYNJ43538B

Product 28

Affected products - Gen Aurg - Minor-Lf, Lot or serial number - 24ABD039, Model or catalogue number - DYNJ45731A

Product 29

Affected products - Breast Pack, Lot or serial number - 24ABD094, Model or catalogue number - DYNJ64376

Product 30

Affected products - Turp Pack Lf, Lot or serial number - 24ABG266 23LBR757, Model or catalogue number - DYNJ41706C

Product 31

Affected products - Feet, Elbow, And Ankle Tegh-Lf, Lot or serial number - 23LBP194, Model or catalogue number - DYNJ46719B

Product 32

Affected products - Lft Hrt Cath Radial Access-Lf, Lot or serial number - 23LBL629, Model or catalogue number - DYNJ47667C

Product 33

Affected products - General Overbed Pack, Lot or serial number - 23LBM922 23KBF156, Model or catalogue number - DYNJ40045B

Product 34

Affected products - Cysto Pack, Lot or serial number - 23LBK417 23LBP883 24ABG215, Model or catalogue number - DYNJ37171A DYNJ40010B

Product 35

Affected products - Apu Line Pack, Lot or serial number - 23KBD998, Model or catalogue number - DYNJ37171A

Product 36

Affected products - Ep Pack, Lot or serial number - 23LBL628, Model or catalogue number - DYNJ40488

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Medline Canada, Medline Custom Procedure Packs - Compromised Breather Pouch.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76287

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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