FDAFDA · Food and drugs·Recall number Z-1653-2013
Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Published July 10, 2013 · Recall initiated: May 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Penlon, Ltd.
- Distributor
- 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.
- Lot
- All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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