Product Wiki · Recalls · Health Canada — Medical Devices

LAPSAC AND INTRODUCER (2015-05-28) — recall 53909

Health Canada — Medical Devices · Canada · 2015-06-26 · Type II

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
53909
Date of alert
2015-06-26
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: Notice advising users of updates to the IFU for the LapSac Surgical Tissue Pouch to remove morcellation from the intended use, warnings and the instructions for use and to add a contraindication. This communication is for informational purposes only and no devices need to be returned. It is intended that all future devices will include the updated IFU. Sales of the device have been suspended until the new IFU can be included with the device.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/lapsac-and-introducer-2015-05-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.