BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-v...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2336-2012.
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2336-2012.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Helix Medical Llc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2336-2012.
Helix Medical LLC
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Helix Medical Llc Recall FAQ
Helix Medical Llc is the subject of a medical implants safety report: BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-v.... The notice was published on March 8, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 2 units are potentially affected.