Product Wiki · Recalls · Health Canada — Medical Devices

Adult IV Set with Rate Flow Regulator, Rate Flow Regulator Extension… — recall 58403

Health Canada — Medical Devices · Canada · 2018-10-26 · Type II

As described by Health Canada — Medical Devices: Adult IV Set with Rate Flow Regulator, Rate Flow Regulator Extension Set, and Rate Flow Regulator IV Set (2018-10-01)

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Agency
Health Canada — Medical Devices
Recall identifier
58403
Date of alert
2018-10-26
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Manufacturer has reviewed recently reported deficiencies related to validation and process control of the manufacturing facility of the rate flow regulator administration sets and, out of an abundance of caution, B. Braun Medical Inc. has elected to remove this product from the market.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/adult-iv-set-rate-flow-regulat

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