Recall Z-1563-2016— 3M Company - Health Care Business

Name: FDA recall Z-1563-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-22

Class II · Terminated

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2016-01-22, terminated 2016-08-25. It names 2 FDA 510(k) clearances: K941748, K902036. Product: 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.. Reason: 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Terminated
Initiated: 2016-01-22
Terminated: 2016-08-25
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

2 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

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/Aerator, models 5XL and 8XL.

Reason for recall

3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.

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