3M Company - Health Care Business: 3M Attest Biological Indicators and Challenge Packs Recalled for Melting Caps

Agency Publication Date: September 26, 2023

Summary

3M Company has recalled approximately 362,748 units of Attest Super Rapid Readout Biological Indicators and Steam Challenge Packs. The recalled products include specific lots of models 1492V, 1496V, 41482V, and 41482VF. These medical devices are being recalled because the caps on the biological indicators may melt, deform, or crack when subjected to standard steam sterilization cycles at 132°C and 135°C. This defect can compromise the sterilization monitoring process in healthcare settings.

Risk

A melted, deformed, or cracked cap can cause the biological indicator to fail or leak during or after the sterilization process. This could lead to inaccurate sterilization monitoring results, potentially resulting in the use of improperly sterilized medical instruments on patients.

What You Should Do

Identify if you have the affected 3M Attest products by checking the REF/model numbers and lot codes on the packaging.
For 3M Attest Super Rapid Readout Biological Indicator (REF 1492V), check for lot codes 33P3X3 (Exp. 12/29/2024) or 33P4NH (Exp. 01/01/2025).
For 3M Attest Super Rapid Readout Steam Challenge Pack (REF 1496V), check for lot codes 33P4NJ (Exp. 01/01/2025) or 33P56T (Exp. 01/02/2025).
For 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack (REF 41482V), check for lot codes 33P3EF (Exp. 12/27/2024), 33P4ND (Exp. 01/01/2025), 33P4NR (Exp. 01/01/2025), 33P5CA (Exp. 01/03/2025), or 33P5XT (Exp. 01/06/2025).
For 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack (REF 41482VF), check for lot codes 41482VF (Exp. 33P4ND) or 33P4YN (Exp. 01/02/2025).
Immediately stop using any products from the affected lots and quarantine them to prevent further use.
Contact your healthcare provider or 3M Company - Health Care Business at 1-888-364-3577 or visit www.3m.com for further instructions regarding the return or replacement of affected products.
For additional questions, contact the FDA at 1-888-463-6332.

Your Remedy Options

Other Action

Healthcare provider or manufacturer consultation

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

Affected Products

Product: 3M Attest Super Rapid Readout Biological Indicator

Model / REF:

1492V

UPC Codes:

50707387762969

30707387762965

Lot Numbers:

33P3X3 (Exp. 12/29/2024)

33P4NH (Exp. 01/01/2025)

Date Ranges: 12/29/2024, 01/01/2025

Product: 3M Attest Super Rapid Readout Steam Challenge Pack

Model / REF:

1496V

UPC Codes:

50707387762983

Lot Numbers:

33P4NJ (Exp. 01/01/2025)

33P56T (Exp. 01/02/2025)

Date Ranges: 01/01/2025, 01/02/2025

Product: 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack

Model / REF:

41482V

UPC Codes:

50707387787276

Lot Numbers:

33P3EF (Exp. 12/27/2024)

33P4ND (Exp. 01/01/2025)

33P4NR (Exp. 01/01/2025)

33P5CA (Exp. 01/03/2025)

33P5XT (Exp. 01/06/2025)

Date Ranges: 12/27/2024, 01/01/2025, 01/03/2025, 01/06/2025

Product: 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack

Model / REF:

41482VF

UPC Codes:

50707387787283

Lot Numbers:

41482VF (Exp. 33P4ND)

33P4YN (Exp. 01/02/2025)

Date Ranges: 01/02/2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92915

Status: Active

Manufacturer: 3M Company - Health Care Business

Sold By: 3M Health Care

Manufactured In: United States

Units Affected: 4 products (79500 devices; 33504 devices; 172,464 devices; 77,280 devices)

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

Identify if you have the affected 3M Attest products by checking the REF/model numbers and lot codes on the packaging.

For 3M Attest Super Rapid Readout Biological Indicator (REF 1492V), check for lot codes 33P3X3 (Exp. 12/29/2024) or 33P4NH (Exp. 01/01/2025).

For 3M Attest Super Rapid Readout Steam Challenge Pack (REF 1496V), check for lot codes 33P4NJ (Exp. 01/01/2025) or 33P56T (Exp. 01/02/2025).

For 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack (REF 41482V), check for lot codes 33P3EF (Exp. 12/27/2024), 33P4ND (Exp. 01/01/2025), 33P4NR (Exp. 01/01/2025), 33P5CA (Exp. 01/03/2025), or 33P5XT (Exp. 01/06/2025).

For 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack (REF 41482VF), check for lot codes 41482VF (Exp. 33P4ND) or 33P4YN (Exp. 01/02/2025).

Immediately stop using any products from the affected lots and quarantine them to prevent further use.

Contact your healthcare provider or 3M Company - Health Care Business at 1-888-364-3577 or visit www.3m.com for further instructions regarding the return or replacement of affected products.

For additional questions, contact the FDA at 1-888-463-6332.

Affected Products

Product: 3M Attest Super Rapid Readout Biological Indicator

Model / REF:

1492V

UPC Codes:

50707387762969

30707387762965

Lot Numbers:

33P3X3 (Exp. 12/29/2024)

33P4NH (Exp. 01/01/2025)

Date Ranges: 12/29/2024, 01/01/2025

Product: 3M Attest Super Rapid Readout Steam Challenge Pack

Model / REF:

1496V

UPC Codes:

50707387762983

Lot Numbers:

33P4NJ (Exp. 01/01/2025)

33P56T (Exp. 01/02/2025)

Date Ranges: 01/01/2025, 01/02/2025

Product: 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack

Model / REF:

41482V

UPC Codes:

50707387787276

Lot Numbers:

33P3EF (Exp. 12/27/2024)

33P4ND (Exp. 01/01/2025)

33P4NR (Exp. 01/01/2025)

33P5CA (Exp. 01/03/2025)

33P5XT (Exp. 01/06/2025)

Date Ranges: 12/27/2024, 01/01/2025, 01/03/2025, 01/06/2025

Product: 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack

Model / REF:

41482VF

UPC Codes:

50707387787283

Lot Numbers:

41482VF (Exp. 33P4ND)

33P4YN (Exp. 01/02/2025)

Date Ranges: 01/02/2025