FDA Device recall Z-1318-2014
3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to ster…
- FDA Device
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to ster… by 3m Health Care Business, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1318-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-17 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | 3m Health Care Business |
| Distribution | US |
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
Identifiers
| code_info | Model SKU Starting S/N Ending S/N 5XL 70-2007-2303-2 721115 721309 5XL 70-2007-2304-0 820174 8202…Model SKU Starting S/N Ending S/N 5XL 70-2007-2303-2 721115 721309 5XL 70-2007-2304-0 820174 820201 5XL 70-2007-2575-5 780066 780102 8XL 70-2006-8493-7 350136 350268 8XL 70-2006-8498-5 450016 450027 4XL 523122, 522205, 522502, 522287, 522655. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1318-2014%22
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