Milex Cervical Dilator (2020-04-08)

Starting date:

April 8, 2020

Posting date:

May 8, 2020

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-72999

Last updated: 2020-05-08

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  Reason
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  Affected products

Affected Products

Milex Cervical Dilator

Reason

CooperSurgical, Inc. (CSI) is issuing a Medical Device Correction for 1 lot of its Milex Cervical Dilator (P/N: MX21). CSI decided to issue a correction because it was found that there was a potential for unsealed pouches. This discrepancy does not meet product release specifications and could potentially increase the risk of infection, because of the compromised sterility.

Affected products