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Health product recall

MILEX OMNIFLEX DIAPHRAGM Size 80 (2015-05-18)

Starting date:
May 18, 2015
Posting date:
July 7, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-54004

Recalled Product

A. MILEX OMNIFLEX DIAPHRAGM Size 80

Reason

CooperSurgical is voluntarily recalling the Milex Omniflex diaphragm - size 80, P/N MXWFBO lot 153309. CooperSurgical quality assurance program identified a size 80 labeled box was incorrectly packaged with a size 85 diaphragm.

Affected products

A.  MILEX OMNIFLEX DIAPHRAGM Size 80

Lot or serial number
  • 153309
Model or catalog number
  • MXWF80
Companies
Manufacturer

Coopersurgical Inc.

95 Corporate Drive

Trumbull

Connecticut

UNITED STATES