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No image published for this recall

Z-med ii-x catheter

Official notice

30 Oct 2024

Last checked

30 Oct 2024

High riskHealth Canada

An official Health Canada notice concerns Z-med ii-x catheter. These units are being recalled due to them being manufactured with the incorrect balloon. The balloon that was placed on this catheter has a lower rated burst pressure than what the PDZ733 is labeled for. The size and length are correct, but the labeled rated burst pressure is different. Recall Start Date: October 25, 2024 Published 2024-10-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76408

Official notice

2024-10-30

The hazard

These units are being recalled due to them being manufactured with the incorrect balloon. The balloon that was placed on this catheter has a lower rated burst pressure than what the PDZ733 is labeled for. The size and length are correct, but the labeled rated burst pressure is different. Recall Start Date: October 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

76408

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Affected products

Product 1

Affected products - Z-Med II-X Catheter, Lot or serial number - JZX-5322, Model or catalog number - PDZ733

Risk / hazard

These units are being recalled due to them being manufactured with the incorrect balloon. The balloon that was placed on this catheter has a lower rated burst pressure than what the PDZ733 is labeled for. The size and length are correct, but the labeled rated burst pressure is different. Recall Start Date: October 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

Manufacturer

Not provided

Phone

Not provided

Brand: Numed, Z-med Ii-x Catheter.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

76408

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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