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