TYRX Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes
TYRX Inc. is recalling 3,460 units of TRYX Antibacterial Envelopes because manufacturing processes were not adequately validated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not yet been reported is classified as High (3).
Plain-English summary
TYRX Inc. is recalling 3,460 units of the TRYX Antibacterial Envelope, a prescription-only medical device indicated for the stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD). The recall is being conducted because the processes of spaying, welding, drying oven, and polymer were not adequately validated.
The affected products are distributed nationwide in the United States. The recall includes units with model numbers CMRM3122 and CMRM3133. Specific lot numbers affected include 15F30614, 15F30614-A, 15H10630, 15K29659, 16B05695, 15F18607, 15G14620, 15J29647, and 16C03706.
Healthcare providers and patients should contact TYRX Inc. for further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
- Manufacturer
- TYRX Inc.
- Hazard
- Affected units
- 3,460
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by TYRX Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · TYRX Inc.
See all →- HighTYRX Absorbable Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes
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