Recall Z-1653-2013— Penlon, Ltd.
Class II · Terminated
Class II FDA medical device recall by Penlon, Ltd., initiated 2013-05-14, terminated 2014-05-12. It names one FDA 510(k) clearance: K002343. 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.. Reason: 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..
- Recalling firm
- Penlon, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-14
- Terminated
- 2014-05-12
- Firm location
- Abingdon, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.