Recall Z-1653-2013
Penlon, Ltd. · initiated May 14, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1653-2013
- Initiated
- May 14, 2013
- Posted by FDA
- July 2, 2013
- Terminated
- May 12, 2014
- Product code
- CAD – Vaporizer, Anesthesia, Non-Heated
- Quantity
- 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.
- Recalling firm
- Penlon, Ltd., Abingdon