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U.S. Department of Health and Human Services

Class 2 Device Recall Penlon Sigma Delta Vaporizer

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  Class 2 Device Recall Penlon Sigma Delta Vaporizer see related information
Date Initiated by Firm May 14, 2013
Date Posted July 02, 2013
Recall Status1 Terminated 3 on May 12, 2014
Recall Number Z-1653-2013
Recall Event ID 65286
510(K)Number K002343  
Product Classification Vaporizer, anesthesia, non-heated - Product Code CAD
Product Delta Vaporizer

An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Code Information All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
Recalling Firm/
Manufacturer		 Penlon, Ltd.
Abingdon Science Park
Barton Lane
Abingdon United Kingdom
Manufacturer Reason
for Recall		 It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Penlon sent an Urgent Field Safety Notice dated May 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded and requested to follow the instructions for daily pre-use checks, initial checks, and servicing. Customers were instructed to distribute the notice to all personnel who need to be aware within their organization and to any organization where the devices are used. For questions regarding this recall call 01235 547000.
Quantity in Commerce 9208 (of which 576 were within the US)
Distribution Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.
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 = CAD and Original Applicant = PENLON LTD.
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