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