FDAClass IIAugust 24, 2016

TRYX Absorbable Antibacterial Envelope Product Usage recall

TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter…

Why was TRYX Absorbable Antibacterial Envelope Product Usage recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

model number CMRM6122 lot number 16E03727 16E05728 model number CMRM6133 lot number 16E02726 16E06729

Product
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter…
Recalling firm
TYRX Inc.
Quantity
2993 units
Distribution
US Nationwide Distribution
Recall date
August 24, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls