Product Wiki · Recalls · Health Canada — Medical Devices

PepGen P-15 and PepGen P-15 Flow (2015-05-04) — recall 53185

Health Canada — Medical Devices · Canada · 2015-06-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
53185
Date of alert
2015-06-01
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: FDA released a safety communication on January 21, 2015 regarding the use of bone graft substitutes containing recombinant proteins or synthetic peptides in patients under age 18. In response to this communication, the warning for the PepGen products will be updated to include a statement indicating product is not for use in patients under the age of 18.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/pepgen-p-15-and-pepgen-p-15-fl

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