Ethicon, Inc.: SURGIFOAM Absorbable Gelatin Powder Kits Recalled for Open Applicator Seals

Agency Publication Date: May 22, 2024

Summary

Ethicon, Inc. is recalling 5,184 units of the SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979). This recall was initiated because some applicator tips within these specific lots were found to have open seals. This defect can compromise the sterility of the medical device, which is used during surgical procedures to help control bleeding.

Risk

An open seal on a medical applicator tip can lead to the loss of a sterile barrier, potentially introducing contaminants or pathogens directly into a patient during surgery. This poses a risk of infection or other serious surgical complications.

What You Should Do

Identify if you have the affected SURGIFOAM Absorbable Gelatin Powder Kit by checking the packaging for Product Number 1979 and UDI/DI 15712123000264.
Check the lot numbers on your kits to see if they match one of the three affected lots: 272574, 272369, or 272770.
Immediately stop using any kits from the affected lots and set them aside to ensure they are not used in medical procedures.
Contact Ethicon, Inc. or your healthcare provider for specific instructions on how to return the affected product and obtain replacements or a refund.
For further information, you may contact the FDA hotline at 1-888-463-6332 or visit the FDA medical device recall website.

Your Remedy Options

Other Action

Contact the manufacturer for instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: SURGIFOAM Absorbable Gelatin Powder Kit, Product Code 1979

Model / REF:

1979

UDI/DI: 15712123000264

Lot Numbers:

272574

272369

272770

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94496

Status: Active

Manufacturer: Ethicon, Inc.

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 5,184 units

Distributed To: Arkansas, California, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Pennsylvania, Tennessee, Texas, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected SURGIFOAM Absorbable Gelatin Powder Kit by checking the packaging for Product Number 1979 and UDI/DI 15712123000264.

Check the lot numbers on your kits to see if they match one of the three affected lots: 272574, 272369, or 272770.

Immediately stop using any kits from the affected lots and set them aside to ensure they are not used in medical procedures.

Contact Ethicon, Inc. or your healthcare provider for specific instructions on how to return the affected product and obtain replacements or a refund.

For further information, you may contact the FDA hotline at 1-888-463-6332 or visit the FDA medical device recall website.