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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Recall Number Z-1653-2013
Classification Class II
Code Info All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
Product Distributed Qty 9208 (of which 576 were within the US)
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.

Event Detail

Event Id 65286
Product Type Devices
Status Ongoing
Recalling Firm Penlon, Ltd.
City Abingdon
State
Country GB
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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