Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 58 of 63
Biomet 3i, LLC
Class II Terminated
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reason: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Z-1168-2014 March 19, 2014 Palm Beach Gardens, FL
Biomet 3i, LLC
Class II Terminated
Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reason: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Z-1170-2014 March 19, 2014 Palm Beach Gardens, FL
Gyrus Medical, Inc
Class II Terminated
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator i...
Reason: Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of th...
Z-1196-2014 March 19, 2014 Osseo, MN
Biomet 3i, LLC
Class II Terminated
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reason: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Z-1171-2014 March 19, 2014 Palm Beach Gardens, FL
Steris Corporation
Class II Terminated
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads ...
Reason: STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.
Z-1166-2014 March 19, 2014 Mentor, OH
Biomet 3i, LLC
Class II Terminated
Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Reason: During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Z-1169-2014 March 19, 2014 Palm Beach Gardens, FL
Djo Surgical
Class II Terminated
FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
Reason: Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization...
Z-1130-2014 March 12, 2014 Austin, TX
Greatbatch Medical
Class I Terminated
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, ...
Reason: Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified th...
Z-1119-2014 March 12, 2014 Minneapolis, MN
Brainlab AG
Class II Terminated
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor sy...
Reason: Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not sui...
Z-0967-2014 February 19, 2014 Feldkirchen, N/A
Symmetry Medical/SSI
Class II Terminated
Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK St...
Reason: The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier.
Z-0833-2014 February 5, 2014 Antioch, TN
Navilyst Medical, Inc.
Class II Terminated
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalo...
Reason: Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
Z-0826-2014 February 5, 2014 Marlborough, MA
Advanced Sterilization Products
Class II Terminated
STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganism...
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possi...
Z-0745-2014 January 22, 2014 Irvine, CA
Advanced Sterilization Products
Class II Terminated
STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorgani...
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possi...
Z-0744-2014 January 22, 2014 Irvine, CA
Advanced Sterilization Products
Class II Terminated
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microor...
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possi...
Z-0746-2014 January 22, 2014 Irvine, CA
Steris Corporation
Class II Terminated
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical st...
Reason: Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solu...
Z-0616-2014 January 8, 2014 Mentor, OH
Advanced Sterilization Products
Class II Terminated
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in t...
Z-0604-2014 January 8, 2014 Irvine, CA
Steris Corporation
Class II Terminated
VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ...
Reason: STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Du...
Z-0605-2014 January 8, 2014 Mentor, OH
Advanced Sterilization Products
Class III Terminated
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: ...
Reason: Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved d...
Z-0434-2014 December 11, 2013 Irvine, CA
Advanced Sterilization Products
Class II Terminated
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyuretha...
Z-0402-2014 December 4, 2013 Irvine, CA
Advanced Sterilization Products
Class II Terminated
STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyuretha...
Z-0403-2014 December 4, 2013 Irvine, CA
Advanced Sterilization Products
Class II Terminated
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Reason: Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be re...
Z-0190-2014 November 20, 2013 Irvine, CA
Advanced Sterilization Products
Class II Terminated
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Reason: Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassett...
Z-0044-2014 October 30, 2013 Irvine, CA
Varian Medical Systems, Inc.
Class II Terminated
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen ...
Reason: The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
Z-0065-2014 October 30, 2013 Charlottesville, VA
Advanced Sterilization Products
Class II Terminated
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer...
Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to...
Z-0043-2014 October 30, 2013 Irvine, CA
Advanced Sterilization Products
Class II Terminated
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Reason: The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's le...
Z-2174-2013 September 18, 2013 Irvine, CA