Recall Z-2640-2023— 3M Company - Health Care Business

Name: FDA recall Z-2640-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-22

Class II · Ongoing

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2023-08-22. It names one FDA 510(k) clearance: K193154. Product: 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes. Reason: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Ongoing
Initiated: 2023-08-22
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K193154 — 3M Attest Super Rapid 5 Steam-Plus Challenge Pack3M Company·cleared 2020-02-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes

Reason for recall

Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.

Data sourced from openFDA. This site is unofficial and independent of the FDA.