Product Wiki · Recalls · Health Canada — Medical Devices

8mm, Tip-Up Fenestrated Grasper, IS40 — recall 73855

Health Canada — Medical Devices · Canada · 2023-06-20 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
73855
Date of alert
2023-06-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Gastroenterology and urology
Product type
Medical devices
Reported risk: The tip-up fenestrated grasper has two versions on the approved product list (APL): 470347-11 and 470347-12. PN 470347-11 uses machined grips, while PN 470347-12 uses grips that have been manufactured via metal-injection molding (MIM). There have been complaints reported for a broken grip issue against the MIM grips. Grip breakage is observed on both upper and/or lower grips. Recall start date: June 8, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/8mm-tip-fenestrated-grasper-is

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.

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