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U.S. Department of Health and Human Services

Class 2 Device Recall Volcano R100 Sterile Equipment Cover

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  Class 2 Device Recall Volcano R100 Sterile Equipment Cover see related information
Date Initiated by Firm February 05, 2016
Date Posted March 03, 2016
Recall Status1 Terminated 3 on March 21, 2017
Recall Number Z-1041-2016
Recall Event ID 73254
510(K)Number K052395  
Product Classification Drape, surgical - Product Code KKX
Product Volcano R100 Sterile Equipment Cover; 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: PBKGB and PBKBG-10 (10 pack): all lots
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Thomas 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KKX and Original Applicant = VOLCANO CORPORATION
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