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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits

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  Class 2 Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits see related information
Date Initiated by Firm August 23, 2011
Date Posted October 06, 2011
Recall Status1 Terminated 3 on January 30, 2013
Recall Number Z-0016-2012
Recall Event ID 59854
Product Classification Anesthesia breathing circuit kit (adult & pediatric) - Product Code OFD
Product DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA:


Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Code Information Lot Numbers: 25402698, 25834829
Recalling Firm/
Manufacturer		 Deroyal Industries, Inc. Lafollette
1501 East Central Ave
La Follette TN 37766-2892
For Additional Information Contact Mr. Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, DeRoyal, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated September 13, 2011 to its customers. The letter describes product, problem, and actions to be taken. Customers are instructed to identify inventory being recalled and place in quarantine to prevent further use. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Customers were asked to complete the attached Recall Response Spreadsheet and return as per the instructions. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Distributors were instructed to perform a sub-recall to their customers. Customers with questions should call 865-362-1037 between 9am and 5pm EST or email recalls@deroyal.com.
Quantity in Commerce 200 units
Distribution Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.
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.
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