Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount o

FDA device recall Z-1653-2013 · posted 2013-07-02 · Terminated

Recall details

Recalling firm

Penlon, Ltd.

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CAD

Quantity affected

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, Lithuni

Date initiated

2013-05-14

Date posted

2013-07-02

Date terminated

2014-05-12

Location

Abingdon, United Kingdom

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