NICO Shepherd's Hook (2018-06-11)
- Starting date:
- June 11, 2018
- Posting date:
- June 29, 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-67144
Affected products
NICO Shepherd's Hook
Reason
On 5th June 2018, a mislabeled Shepherd's Hook was identified during processing at NICO's contract manufacturer, primo medical group ("primo"). The mislabeled hook included a transport/storage label rather than the regulatory label containing key product information such as part number, lot number, expiration date, etc. The transport/storage label is meant to be applied to the corrugated shipping box rather than the pouch.
Affected products
NICO Shepherd's Hook
Lot or serial number
37LG1834
Model or catalog number
NN-8024
Companies
- Manufacturer
-
NICO Corporation
250 E 96th St, Suite 125
INDIANAPOLIS
46240
Indiana
UNITED STATES