Health product recall

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

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

Single-Use Colpo-Pneumo Occluder

Lot or serial number

244131

Model or catalog number

CPO-6

Companies
Manufacturer
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES