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Recall Observatory FDA recall evidence

Device 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.

Z-1653-2013

May 14, 2013

Class II

Product summary

Firm
Penlon, Ltd.
Event
Event 65286
Status
Terminated
Classification
Class II
Quantity
9208 (of which 576 were within the US)
Official record key
device-enforcement:Z-1653-2013

Official wording

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.

Code information: All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.