FDA Medical Device Recalls (openFDA)
Penlon, Ltd.: Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
- Recall number
- Z-1653-2013
- Recalling firm
- Penlon, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2013-05-14
- Posted
- 2013-07-02
- Terminated
- 2014-05-12
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- 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.
- Lot, serial or model codes
- All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
- 510(k) numbers
- ["K002343"]
- PMA numbers
- not on file
- Product code
- CAD
- Firm FEI
- 3002807907
- Firm city
- Abingdon
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28