Reported Aug 24, 2016 · Terminated
TRYX Absorbable Antibacterial Envelope 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 Absorbable
- Antibacterial Envelope Product UsageIndicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
- Lot codes and dates
- model number CMRM6122 lot number 16E03727 16E05728 model number CMRM6133 lot number 16E02726 16E06729
- Amount recalled
- 2993 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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