Z-1041-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2016
- Initiation Date
- February 5, 2016
- Termination Date
- March 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1355 total
Product Description
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
Reason for Recall
Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
Distribution Pattern
Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Code Information
REF numbers: PBKGB and PBKBG-10 (10 pack): all lots