TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1552-2014.
The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1552-2014.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1552-2014.
Tenex Health Inc
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Tenex Health Inc Recall FAQ
Tenex Health Inc is the subject of a surgical devices safety report: TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the.... The notice was published on April 14, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 9,927 units are potentially affected.