Recall Z-1318-2014— 3M Company - Health Care Business

Name: FDA recall Z-1318-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-17

Class II · Terminated

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2014-03-17, terminated 2015-01-22. It names 3 FDA 510(k) clearances: K941748, K902036, K812867. Product: 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.. Reason: Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20.

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Terminated
Initiated: 2014-03-17
Terminated: 2015-01-22
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

3 on FDA's record

K941748 — STERI-VAC GAS STERILIZER MODEL 8XL3M Health Care, Ltd.·cleared 1994-12-02
K902036 — STERI-VAC GAS STERILIZER MODEL 5XL3M Company·cleared 1990-07-19
K812867 — STERI-VAC #400C GAS STERILIZER3M Company·cleared 1981-11-02

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" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.

Reason for recall

Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20

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