PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 9, 2016 Initiated: February 5, 2016 #Z-1042-2016

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.

Details

Recalling Firm
Volcano Corporation
Units Affected
1355 total
Distribution
Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Location
Rancho Cordova, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Volcano Corporation. Units affected: 1355 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2016. Severity: Moderate. Recall number: Z-1042-2016.

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