Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.

FDA device recall Z-2067-2011 · posted 2011-04-28 · Terminated

Recall details

Recalling firm

Therakos Inc

Reason for recall

Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LNR

Quantity affected

4,323 kits

Distribution

Worldwide Distribution

Date initiated

2011-02-01

Date posted

2011-04-28

Date terminated

2014-03-13

Location

Raritan, NJ