ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
Siemens Medical Solutions USA
Class I - Dangerous
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Helena Laboratories
Class I - Dangerous
Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
cobas c513 Analyzer
Roche Diagnostics Operations
Class I - Dangerous
Quality issue with high pressure solenoid valves
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Roche Diagnostics Operations
Class I - Dangerous
Quality issue with high pressure solenoid valves
CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Integra LifeSciences
Class I - Dangerous
A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument
AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
Boston Scientific
Class I - Dangerous
Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
Norm-O-Temp model 111Z
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Flexible Intubation Fiberscope, Model # 11301AB1
Karl Storz Endoscopy
Class I - Dangerous
The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
Fujifilm FDR Go Plus mobile X-ray system
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)
Norm-O-Temp model 111W
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Class I - Dangerous
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Class I - Dangerous
Reversed expiration and manufacturing date on the label
CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
CareFusion 303
Class I - Dangerous
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Angiodynamics
Class I - Dangerous
The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.
FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160
B. Braun Medical
Class I - Dangerous
The filter capacity is not achieved due to damage of the filter membrane.