Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
Prodimed Plastimed Division
Class I - Dangerous
Lack of assurance of sterility
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
Prodimed Plastimed Division
Class I - Dangerous
Lack of assurance of sterility
Class I - Dangerous
Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
Class I - Dangerous
Incorrect product labeling.
Class I - Dangerous
Device and tray that houses the device did not pass steam sterilization process validation testing
Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Resource Optimization & Innovation
Class I - Dangerous
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Class I - Dangerous
Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade possibly resulting in a loose blade.
Class I - Dangerous
Device and tray that houses the device did not pass steam sterilization process validation testing
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.
Resource Optimization & Innovation
Class I - Dangerous
There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.
Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Medtronic Navigation
Class I - Dangerous
There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
INARI MEDICAL
Class I - Dangerous
The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.
Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
da Vinci SP surgical system
Intuitive Surgical
Class I - Dangerous
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Class I - Dangerous
In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.