Recall Z-2539-2016— TYRX Inc.

Name: FDA recall Z-2539-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-29

Class II · Terminated

Class II FDA medical device recall by TYRX Inc., initiated 2016-06-29, terminated 2017-12-12. It names one FDA 510(k) clearance: K063091. Product: TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD). Reason: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated..

Recalling firm: TYRX Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-29
Terminated: 2017-12-12
Firm location: Monmouth Junction, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K063091 — PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601Tyrx Pharma, Inc.·cleared 2008-01-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.