Product Wiki · Recalls · Health Canada — Medical Devices

ConvaTec's Nelaton Catheter — recall 58593

Health Canada — Medical Devices · Canada · 2019-01-23 · Type II

As described by Health Canada — Medical Devices: ConvaTec's Nelaton Catheter - PVC, Catheters for Women - PVC, Tiemann Catheters - PVC (2018-12-04)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
58593
Date of alert
2019-01-23
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Internal assessment of product packaging integrity has confirmed that these devices are not meeting the expectations. Transportation testing conducted to the product packaging failed confirming the potential for a breach in the sterile barrier. Using a non-sterile device on a patient may expose the patient to infectious agents increasing the patient risk of developing infection.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/convatec-s-nelaton-catheter-pv

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