Recall Z-1041-2016
Volcano Corporation · initiated February 5, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
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.
FDA-determined cause: Labeling False and Misleading
Action taken
Urgent Medical Device letters were sent to affected consignees the week of February 8, 2016 by Fed Ex or UPS so delivery can be tracked. For OUS consignees, the same letter will be sent and they will execute delivery to customers and track responses.
Details
- Recall number
- Z-1041-2016
- Initiated
- February 5, 2016
- Posted by FDA
- March 3, 2016
- Terminated
- March 21, 2017
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Quantity
- 1355 total
- Distribution
- Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
- Recalling firm
- Volcano Corporation, Rancho Cordova, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1042-2016 Class II | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile…Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may… | 02/05/2016Terminated |