3M Company - Health Care Business: 3M Tegaderm CHG I.V. Securement Dressing Recalled for Contamination

Agency Publication Date: October 9, 2024

Summary

3M Company is recalling 10,000 units of 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressings (Model REF 1658R) due to contamination with a foreign substance. This defect can compromise the sterility or integrity of the medical dressing, which is used to secure intravenous lines. Consumers and healthcare providers should check their inventory for affected lot number 33WWRRR. If you have these dressings, you should contact your healthcare provider or 3M for instructions on how to proceed.

Risk

The presence of a foreign substance in a sterile medical dressing can introduce contaminants directly to a patient's intravenous insertion site, potentially leading to infections or other medical complications.

What You Should Do

Check your medical supplies for 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressings with the model number REF 1658R.
Verify if your product belongs to lot number 33WWRRR. You can find this on the product carton (UDI/DI 10707387802223) or the individual dressing package (UDI/DI 30707387802227).
Do not use any dressings from the affected lot number 33WWRRR.
Contact your healthcare provider or 3M Company directly at their Health Care Business division to report affected stock and receive instructions on potential replacement or disposal.
For further information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

manufacturer or healthcare provider consultation

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

Affected Products

Product: 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Model / REF:

REF 1658R

UDI/DI 10707387802223

UDI/DI 30707387802227

Lot Numbers:

33WWRRR

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95273

Status: Active

Manufacturer: 3M Company - Health Care Business

Sold By: Health care distributors; Medical facilities

Manufactured In: United States

Units Affected: 10,000 units

Distributed To: Nationwide

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

Check your medical supplies for 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressings with the model number REF 1658R.

Verify if your product belongs to lot number 33WWRRR. You can find this on the product carton (UDI/DI 10707387802223) or the individual dressing package (UDI/DI 30707387802227).

Do not use any dressings from the affected lot number 33WWRRR.

Contact your healthcare provider or 3M Company directly at their Health Care Business division to report affected stock and receive instructions on potential replacement or disposal.

For further information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.