Device product
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.
Z-1041-2016
Product summary
- Event
- Event 73254
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1355 total
- Official record key
device-enforcement:Z-1041-2016
Official wording
Reason: 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.
Code information: REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
Distribution pattern: Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Derived failure modes
-
Unknown
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.