1,565 results found for sterilization
Page 11 of 63
American Contract Systems, Inc.
Class IIOngoing
Pediatric Heart SJH, REF SJPH34K
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0176-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Robotics Pack SAH, REF SAR530M
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0174-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
General Pack, REF BBGP31C
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0171-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Robotics Pack, REF SSRO22D
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0179-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Vasc. Open CVOR SJH, REF SJVO56B
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0177-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Robotics Pack, REF SJVO56B
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0178-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
CVS PCSU SJH, REF SJCV48J
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0175-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Cath Cardiac Pack, REF IHCC03V
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0182-2024November 1, 2023Temple Terrace, FL
3M Company - Health Care Business
Class IIOngoing
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Reason: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Stea...
Z-2639-2023October 4, 2023Saint Paul, MN
3M Company - Health Care Business
Class IIOngoing
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Reason: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Stea...
Z-2638-2023October 4, 2023Saint Paul, MN
3M Company - Health Care Business
Class IIOngoing
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
Reason: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Stea...
Z-2637-2023October 4, 2023Saint Paul, MN
3M Company - Health Care Business
Class IIOngoing
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
Reason: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Stea...
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, pr...
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, pr...
Z-2605-2023September 27, 2023Austin, TX
Encore Medical, LP
Class IIOngoing
DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, pr...
Z-2604-2023September 27, 2023Austin, TX
Encore Medical, LP
Class IIOngoing
DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, pr...
Z-2607-2023September 27, 2023Austin, TX
Encore Medical, LP
Class IIOngoing
DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Ne...
Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, pr...
Z-2606-2023September 27, 2023Austin, TX
Olympus Corporation of the Americas
Class IIOngoing
Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Reason: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights th...
Z-2342-2023August 16, 2023Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Reason: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights th...
Z-2340-2023August 16, 2023Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Reason: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights th...
Z-2344-2023August 16, 2023Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Reason: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights th...
Z-2343-2023August 16, 2023Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
Reason: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights th...
Z-2341-2023August 16, 2023Center Valley, PA
Scican Ltd.
Class IIOngoing
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
Reason: The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized ste...
Z-2285-2023August 9, 2023North York, N/A
Scican Ltd.
Class IIOngoing
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303
Reason: The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized ste...
Z-2286-2023August 9, 2023North York, N/A
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Reason: Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after f...