Z-1653-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2013
- Initiation Date
- May 14, 2013
- Termination Date
- May 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9208 (of which 576 were within the US)
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.
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.
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.
Code Information
All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.