Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-1042-2016

February 05, 2016

Class II

Product summary

Firm
Volcano Corporation
Event
Event 73254
Status
Terminated
Classification
Class II
Quantity
1355 total
Official record key
device-enforcement:Z-1042-2016

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: 891BG and 891BG-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

    reason.no_named_rule · v1.0.0

    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.