Product Wiki · Recalls · Health Canada — Medical Devices

Caresite Luer Access Device (2013-10-15) — recall 50406

Health Canada — Medical Devices · Canada · 2013-10-28 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50406
Date of alert
2013-10-28
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: B. Braun Medical inc. (BBMI) has identified the instruction for use (IFU) on the Caresite Luer Access Device (Product 415128) exhibits translated instructions in the incorrect section and/or partially missing translation instructions. Specifically, the French section is primarily Spanish and the Spanish section is primarily Italian. It should be noted, all other content information including the warning section is translated correctly and accurate on the IFU. At this time, no patient harm or adverse impact has been noted as a result of this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/caresite-luer-access-device-20

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