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Surgical Instruments

🏥 Medical Devices • 7,015 recalls

DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

Beckman Coulter Biomedical GmbH

Class I - Dangerous

The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system .

Jun 17, 2020 Surgical Instruments Nationwide View Details →

Speed Stitch Needle Cassette

ArthroCare

Class I - Dangerous

Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.

Aug 17, 2020 Surgical Instruments Nationwide View Details →

Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.

Integra LifeSciences

Class I - Dangerous

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Aug 4, 2020 Surgical Instruments Nationwide View Details →

Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

Randox Laboratories

Class I - Dangerous

An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.

Aug 11, 2020 Surgical Instruments Nationwide View Details →

Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.

Randox Laboratories

Class I - Dangerous

An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional pipette washes can be implemented as described in the technical bulletin. Interference to the Lactate Dehydrogenase (LOH) reagent would be observed as inconsistencies in Quality Control recovery, which may lead to a delay in running patient samples, or erroneous elevated test results.

Aug 11, 2020 Surgical Instruments Nationwide View Details →

13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.

Integra LifeSciences

Class I - Dangerous

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Aug 4, 2020 Surgical Instruments Nationwide View Details →

Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.

Integra LifeSciences

Class I - Dangerous

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Aug 4, 2020 Surgical Instruments Nationwide View Details →

FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

Inpeco S.A.

Class I - Dangerous

Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results

Aug 7, 2020 Surgical Instruments Nationwide View Details →

ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).

Intuitive Surgical

Class I - Dangerous

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

Jun 10, 2020 Surgical Instruments View Details →

PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →

PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200

Class I - Dangerous

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Jul 29, 2020 Surgical Instruments Nationwide View Details →
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