Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cov
FDA device recall Z-1042-2016 · posted 2016-03-03 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- 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.
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 1355 total
- Distribution
- Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
- Date initiated
- 2016-02-05
- Date posted
- 2016-03-03
- Date terminated
- 2017-03-21
- Location
- Rancho Cordova, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERILE EQUIPMENT COVERS (K052395) | Volcano Corporation | 2005-12-01 |