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Health product recall

RUMI Arch Products

Starting date:
November 2, 2012
Posting date:
January 7, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices, Product Safety
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-16503

Recalled Products

A. RUMI Arch Reusable Uterine Manipulator Handle
B. RUMI Advincula Arch

Reason

Excessive pressure exerted on the uterine tip when attached to the arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle.

Affected products

A. RUMI Arch Reusable Uterine Manipulator Handle

Lot or serial number

More than 1,000 numbers, contact manufacturer.

Model or catalog number

UMH700

Companies
Manufacturer
Coopersurgical Inc.

B. RUMI Advincula Arch

Lot or serial number

More than 1,000 numbers, contact manufacturer.

Model or catalog number

UMH750

Companies
Manufacturer
Coopersurgical Inc.