Class 2 Device Recall Midmark M11 Ultra Steam Sterilizer

[Autoclave.Guru]

MIDMARK CORP.
	SUBSTANTIALLY EQUIVALENT	8
1. K023348 MIDMARK M9 ULTRACLAVE STEAM STERILIZER
2. K090670 MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
3. K163337 Midmark and Ritter M9 and M11 UltraClave® Automati ...
4. K900432 MODEL #M8 ELECTRONIC STERILIZER
5. K911322 MODEL #M9 ULTRACLAVE STEAM STERILIZER
6. K936181 MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
7. K990189 MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STE ...
8. K992744 MIDMARK M4*9 EASYCLAVE STEAM STERILIZER

https://www.accessdata.fda.gov/scrip...plc.cfm?id=FLE

[Autoclave.Guru]

Class 2 Device Recall Tabletop Steam Sterilizers.

March 05, 2003 April 01, 2003 Terminated 3 on January 20, 2004 Z-0704-03 25727 Sterilizer, Steam - Product Code FLE Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers. Models: M7-011 and M7-014; Serial Numbers: MH006260 to MH006269, MH006273, MH006277 to MH006282, MH006284 to MH006290, MH006294, ML007606 to ML007608, ML007610, ML007637 to ML007642. Midmark Corp 60 Vista Dr PO Box 286 Versailles OH 45380 The pressure relief valve may fail to open properly.

[Autoclave.Guru]

3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.	2	Apr-24-2016	3M Company - Health Care Business
AMSCO 400 and AMSCO C Small Steam Sterilizers	3	Nov-04-2015	Steris Corporation
Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for ster...	2	Aug-13-2015	Advanced Sterilization Products
AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 ...	2	Apr-30-2015	Steris Corporation
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model nu...	3	Feb-10-2015	Lacrimedics Inc
STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System wh...	2	Dec-22-2014	Advanced Sterilization Products
STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System ...	2	Dec-22-2014	Advanced Sterilization Products
STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System whi...	2	Dec-22-2014	Advanced Sterilization Products
STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System ...	2	Dec-22-2014	Advanced Sterilization Products
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System wh...	2	Dec-22-2014	Advanced Sterilization Products

[Autoclave.Guru]

3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/...	2	Apr-02-2014	3M Company - Health Care Business
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a g...	2	Jan-14-2014	Advanced Sterilization Products
STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a gener...	2	Jan-14-2014	Advanced Sterilization Products
STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a gen...	2	Jan-14-2014	Advanced Sterilization Products
AMSCO® Evolution® steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transporta...	2	Dec-11-2013	Steris Corporation
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general pu...	2	Nov-26-2013	Advanced Sterilization Products
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general...	2	Nov-26-2013	Advanced Sterilization Products
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Par...	2	Oct-22-2013	Advanced Sterilization Products
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose ste...	2	Oct-22-2013	Advanced Sterilization Products
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperatur...	2	Sep-10-2013	Advanced Sterilization Products

[Autoclave.Guru]

New SearchExport to Excel | Help
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Produc...	2	Jul-29-2013	Steritec Products Mfc. Co., Inc.
Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Pr...	2	Jul-29-2013	Steritec Products Mfc. Co., Inc.
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product...	2	Jul-29-2013	Steritec Products Mfc. Co., Inc.
Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/...	2	Jul-29-2013	Steritec Products Mfc. Co., Inc.
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Dist...	2	Jul-29-2013	Steritec Products Mfc. Co., Inc.
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization Sys...	2	Mar-30-2013	Advanced Sterilization Products
STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System ...	2	Mar-30-2013	Advanced Sterilization Products
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processe...	2	Mar-26-2013	Advanced Sterilization Products
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable mater...	2	Mar-06-2013	Steris Corporation
STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature genera...	2	Jan-09-2013	Advanced Sterilization Products

[Autoclave.Guru]

3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a ...	2	Oct-09-2012	3M Company - Health Care Business
Verify® Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mento...	2	Sep-20-2012	Steris Corporation
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are l...	3	Sep-07-2012	Advanced Sterilization Products
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are...	3	Sep-07-2012	Advanced Sterilization Products
The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to ass...	2	May-11-2012	Steris Corporation
STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; P...	2	Jan-13-2012	Advanced Sterilization Products
Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles,...	2	Jan-11-2012	Midmark Corportation
STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD St...	2	Jan-11-2012	Advanced Sterilization Products
Amsco® V-PRO 1 and Amsco® V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 03...	2	Aug-19-2011	Steris Corporation
Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indi...	2	Oct-20-2009	Advanced Sterilization Products

[Autoclave.Guru]

Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to ste...	2	Jun-30-2009	Advanced Sterilization Products
STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a low-temp...	2	Jun-15-2009	Advanced Sterilization Products
STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a low-temp...	2	Jun-15-2009	Advanced Sterilization Products
STERRAD NX Sterilizer, Product Code 10033 Low temperature sterilizers that use hydrogen peroxide ...	2	Dec-02-2008	Advanced Sterilization Products
STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware compone...	2	Nov-21-2008	Advanced Sterilization Products
STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable ...	2	Aug-08-2008	Advanced Sterilization Products
STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusab...	2	Aug-08-2008	Advanced Sterilization Products
STERRAD 100S Sterilizer, Product Code: 10101, Advanced Sterilization Products, Irvine, CA	2	Feb-08-2008	Advanced Sterilization Products
STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CA	2	Feb-08-2008	Advanced Sterilization Products
STERRAD NX Sterilizer, Product Code: 10033, Advanced Sterilization Products, Irvine, CA	2	Feb-08-2008	Advanced Sterilization Products

[Autoclave.Guru]

STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CA	2	Feb-08-2008	Advanced Sterilization Products
STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customer...	2	Feb-07-2008	Advanced Sterilization Products
Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).	2	Aug-23-2007	Steris Corp
Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers.