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U.S. Department of Health and Human Services

Class 2 Device Recall Volcano SpinVision Sterile Equip cover II

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 Class 2 Device Recall Volcano SpinVision Sterile Equip cover IIsee related information
Date Initiated by FirmFebruary 05, 2016
Date PostedMarch 03, 2016
Recall Status1 Terminated 3 on March 21, 2017
Recall NumberZ-1042-2016
Recall Event ID 73254
510(K)NumberK052395 
Product Classification Drape, surgical - Product Code KKX
ProductVolcano 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.
Code Information REF numbers: 891BG and 891BG-10 (10 pack): all lots
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information ContactThomas J. Brennan
858-764-1320
Manufacturer 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 2		Labeling False and Misleading
ActionUrgent 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 Commerce1355 total
DistributionDistributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KKX
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