Z-1042-2016Class II

Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are...

Name: Z-1042-2016 Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are...
Creator: Volcano Corporation
Published: 2016-02-05
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2016-02-05 / Terminated / root cause: labeling and UDI

FDA source

Volcano Corporation began a recall of 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... on 2016-02-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1042-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-05
Posted: 2016-03-03
Terminated: 2017-03-21
Recalling firm: Volcano Corporation
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.
Product code: KKX Drape, Surgical, Antimicrobial
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1355 total
Distribution: Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Product codes and lots: REF numbers: 891BG and 891BG-10 (10 pack): all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1042-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1041-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03
Z-1042-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03

Product code KKX

K052395Class IISterile Equipment CoversVolcano Corporation / cleared 2005-12-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)