Recall Z-1042-2016 ยท KKX Drape, Surgical, Antimicrobial
Volcano Corporation
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.
| Date | Mar 3, 2016 (initiated Feb 5, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | 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. |
| Quantity | 1355 total |
| Distribution | Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052395 | STERILE EQUIPMENT COVERS Volcano Corporation, Dec 1, 2005 |