FDA Device

TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)

Hazard

TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.

What You Should Do

Remedy

Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter identified the affected product problem and actions to be taken. Customers are asked to immediately remove and quarantine all unused product that remains in inventory, return unused product to Medtronic and contacted the local Medtronic representative or Customer Service at 800-848-9300 to assist with the return and credit of unused product. Medtronic will provide credit for all non-expired, unused product. The customer should complete the attached Customer Confirmation Certificate and email to RS.CFQFCA@Medtronic.com or fax to Medtronic at 651-367-0612 Attention Customer Focused Quality.

Products

TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Brand
TYRX Inc.
UPC
model number  CMRM3122  lot number   15F30614 15F30614-A 15H10630 15K29659 16B05695  model number CMRM3133  lot number   15F18607 15G14620 15J29647 16C03706

Units Affected

3460 units