FDA Enforcement
Class II
Terminated
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.
Recall: Z-1041-2016
·
Reported March 9, 2016
Enforcement
- Recall Number
- Z-1041-2016
- Event ID
- 73254
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Volcano Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 9, 2016
- Initiation Date
- February 5, 2016
- Classification Date
- March 3, 2016
- Termination Date
- March 21, 2017
- Address
- 2870 Kilgore Rd, N/A, Rancho Cordova, CA, 95670-6133, United States
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
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 Info
REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
Distribution
Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Quantity
1355 total