Recall Z-1041-2016— Volcano Corporation
Class II · Terminated
Class II FDA medical device recall by Volcano Corporation, initiated 2016-02-05, terminated 2017-03-21. It names one FDA 510(k) clearance: K052395. 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.. 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..
- Recalling firm
- Volcano Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-05
- Terminated
- 2017-03-21
- Firm location
- Rancho Cordova, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.