Health product recall

CooperSurgical Single-Use Elastic Stays (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-67852

Affected products

CooperSurgical Single-Use Elastic Stays

Reason

CooperSurgical Inc is recalling one lot of the 3 mm Elastic Stays (P/N: 3314-1G), three lots of the 5 mm Elastic Stays (P/N: 3316-1G) and seven lots of the dual lead elastic stays (P/N: 3550-1G) 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 an inspection of returned merchandise.

Affected products

CooperSurgical Single-Use Elastic Stays

Lot or serial number

244667
245603
245964

Model or catalog number

3314-1G
3316-1G
3550-1G

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