FDA Device recall Z-1042-2016
Volcano SpinVision Sterile Equip cover II
- FDA Device
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of Volcano SpinVision Sterile Equip cover II by Volcano, citing 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 wr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1042-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-05 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Volcano |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | REF numbers: 891BG and 891BG-10 (10 pack): all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1042-2016%22
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