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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

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

Product Detail

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