Product Wiki · Recalls · Health Canada — Medical Devices

ACROBAT V Vacuum Off-Pump System (2014-08-18) — recall 52411

Health Canada — Medical Devices · Canada · 2014-09-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
52411
Date of alert
2014-09-16
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to these products. As a result, there is a potential for the pouch integrity to be compromised, which may result in compromised sterility of the product. If the compromised product is used in surgery there is a potential risk of infection for the patient.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/acrobat-v-vacuum-pump-system-2

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