FDA Medical Device Recalls (openFDA)
Therakos Inc: Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.
- Recall number
- Z-2067-2011
- Recalling firm
- Therakos Inc
- Product
- Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.
- Status
- Terminated
- Initiated
- 2011-02-01
- Posted
- 2011-04-28
- Terminated
- 2014-03-13
- Reason
- Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).
- Root cause
- Process control
- Action
- Therakos notified all direct Therakos US and ex-US End Users and Distributor consignees via Federal Express courier with an Urgent Product Correction Notification, dated 2/1/2011. The letter identified the reason for recall along with the affected product. Customers were to immediately discontinue using and discard the identified affected lots of the product. Customers were to use alternative lots. In order to receive credit for the discarded product, customers were to complete the attached confirmation of receipt and destruction. If there were any questions, a question and answer section was provided but additional questions could be directed towards Therakos Customer Service Center at 1-800-828-6316, Option 2,1.
- Quantity
- 4,323 kits
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Lots Y703 through Y707 and Y709 though Y726 Lot Number - Expiration Date Y703, 1/1/2015 Y704, 2/1/2015 Y705, 2/1/2015 Y706, 2/1/2015 Y707, 2/1/2015 Y709, 2/1/2015 Y710, 3/1/2015 Y711, 3/1/2015 Y712, 3/1/2015 Y713, 3/1/2015 Y714, 3/1/2015 Y715, 3/1/2015 Y716, 3/1/2015 Y717, 4/1/2015 Y718, 4/1/2015 Y719, 4/1/2015 Y720, 4/1/2015 Y721, 4/1/2015 Y722, 4/1/2015 Y723, 4/1/2015 Y724, 4/1/2015 Y725, 5/1/2015; and Y726, 5/1/2015.
- 510(k) numbers
- not on file
- PMA numbers
- ["P860003"]
- Product code
- LNR
- Firm FEI
- 2523595
- Firm city
- Raritan
- Firm state
- NJ
- Firm country
- not on file
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