Gentell Hydrogel Ag 4x4 (model GEN-11420) is recalled due to improper FDA registration. This product is used for wound care under healthcare supervision. Consumers should contact the manufacturer for details.
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Gentell Hydrogel Ag 4x4 (model GEN-11420) is being recalled because it wasn't properly registered with the FDA. This product is used for wound care under healthcare professional supervision. The recall doesn't pose a direct safety risk to users but requires correction of regulatory compliance.
The product was not properly registered with the FDA during an audit. This regulatory issue does not directly affect the product's safety or effectiveness but requires correction to meet legal compliance standards.
Healthcare professionals and patients using Gentell Hydrogel Ag 4x4 (model GEN-11420) for wound care. Those most at risk are individuals relying on this product for medical treatment under healthcare supervision.
Check for the model number GEN-11420 on the product packaging. This hydrogel is used for wound care under healthcare professional supervision.
Reach out to Gentell, Inc for specific instructions on how to address the FDA registration issue.
No, the recall is due to improper FDA registration, not a safety hazard. The product is safe for use under healthcare supervision.
Contact Gentell, Inc directly for instructions on how to address the registration issue.
The recall does not indicate any risk of injury; it is a regulatory compliance issue.
We’ve drafted a message you can send Gentell to request your refund or repair — edit it as you like.
Subject: Recall Z-1624-2020 — Gentell Gentell Hello, I own a Gentell that is covered by recall Z-1624-2020 from Gentell. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
