Single-Use Colpo-Pneumo Occluder (2018-09-04)

Starting date:

September 4, 2018

Posting date:

September 28, 2018

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-67850

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  Reason
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  Affected products

Affected products

Single-Use Colpo-Pneumo Occluder

Reason

CooperSurgical Inc is recalling twenty-six lots of the Colpo-Pneumo Occluder (P/N: CPO-6) because of the potential for unsealed pouches. The product is sterilized prior to distribution, but an unsealed pouch tampers with the sterility of the product as it results in the potential exposure of the device to foreign materials, including biological agents. The condition that led to this recall was discovered by CSI during a complaint investigation unrelated to the packaging seal

Affected products