Z-1042-2016 Class II Terminated
FDA device recall Z-1042-2016 was initiated by Volcano Corporation on February 5, 2016 and is designated Class II. 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 b… The recall status is terminated (terminated March 21, 2017). Affected quantity: 1355 total.
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 SpinVision Sterile Equip cover II; 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: 891BG and 891BG-10 (10 pack): all lots