Class I - Dangerous
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
May result in readings outside of the expected accuracy range.
The tracheal and brochial swivel connectors are incorrectly labeled.
Patients have experienced a bad taste associated with the filters.
May result in readings outside of the expected accuracy range.
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Maquet Cardiovascular Us Sales
Class I - Dangerous
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Young Dental Manufacturing Co
Class I - Dangerous
Product shelf life may be shorter than that indicated on the label.
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
Roche Diagnostics Operations
Class I - Dangerous
Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
Class I - Dangerous
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
Class I - Dangerous
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Medtronic Neuromodulation
Class I - Dangerous
There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.
Comprehensive RS Cleat CAP, Item No. 110300
Zimmer Biomet
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Vital Scientific N.V.
Class I - Dangerous
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
Zimmer Biomet
Class I - Dangerous
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Class I - Dangerous
The epoxy on Apex manufactured epoxy-coated instruments can pop off.