Reported Aug 24, 2016 · Terminated
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or…
TYRX Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TYRX Inc. · 1 Deerpark Dr Ste G · Monmouth Junction, NJ · 08852-1920
Is this the product you have?
- TRYX Antibacterial
- Envelope Rx Only Product UsageIndicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
- Lot codes and dates
- model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706
- Amount recalled
- 3460 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new TYRX Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.