Medical Devices Recalls

Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

Microbiologics

Class I - Dangerous

Product with incorrect shelf life.

Apr 9, 2019 Other Medical Devices Nationwide View Details →

CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS

Accuray Incorporated

Class I - Dangerous

There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.

Apr 10, 2018 Infusion Pumps View Details →

Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.

Abbott Gmbh & Co. KG

Class I - Dangerous

Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.

Apr 15, 2019 Diagnostic Equipment Nationwide View Details →

Sterile Nail Nipper, Barrel Spring (I68400), Sterile

Centurion Medical Products

Class I - Dangerous

Compromised seal on the sterile barrier pouch.

Mar 29, 2019 Other Medical Devices Nationwide View Details →

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small

Zimmer Biomet

Class I - Dangerous

Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

Apr 18, 2019 Implants & Prosthetics View Details →

BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536

Becton Dickinson & Company

Class I - Dangerous

Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.

Mar 1, 2019 Surgical Instruments View Details →

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium

Zimmer Biomet

Class I - Dangerous

Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

Apr 18, 2019 Implants & Prosthetics View Details →

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F

OriGen Biomedical

Class I - Dangerous

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

Jan 17, 2017 Other Medical Devices Nationwide View Details →

NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

NxStage Medical

Class I - Dangerous

Certain lots were mislabeled with incorrect product number.

Apr 11, 2019 Other Medical Devices Nationwide View Details →

IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

Philips North America

Class I - Dangerous

The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

Mar 28, 2019 Diagnostic Equipment Nationwide View Details →

Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.

Flowonix Medical

Class I - Dangerous

The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.

Mar 21, 2019 Infusion Pumps Nationwide View Details →

Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.

Leica Microsystems

Class I - Dangerous

The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.

May 3, 2019 Diagnostic Equipment View Details →

Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.

Flowonix Medical

Class I - Dangerous

The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.

Mar 21, 2019 Infusion Pumps Nationwide View Details →

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F

OriGen Biomedical

Class I - Dangerous

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

Jan 17, 2017 Other Medical Devices Nationwide View Details →

Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.

Flowonix Medical

Class I - Dangerous

The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode. Error 115 can also occur if dendrites form or if the pump is dropped.

Mar 21, 2019 Infusion Pumps Nationwide View Details →

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F

OriGen Biomedical

Class I - Dangerous

Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.

Jan 17, 2017 Other Medical Devices Nationwide View Details →

IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

Philips North America

Class I - Dangerous

The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

Mar 28, 2019 Diagnostic Equipment Nationwide View Details →

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Guide Extra Large

Zimmer Biomet

Class I - Dangerous

Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

Apr 18, 2019 Implants & Prosthetics View Details →

Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. Device Description: The AXS Infinity LS Plus Long Sheath is a single lumen, flexible, variable stiffness long sheath with an 0.091 inch inner diameter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Infinity LS Plus Long Sheath shaft has a 10 cm lubricious coating at the distal end to reduce friction during use. The inner lumen of the AXS Infinity LS Plus Long Sheath is compatible with 6F or smaller catheters. Each package includes one AXS Infinity LS Plus Long Sheath (INC- 11196-70, INC-11196-80, or INC-11196-90), one Dilator, and one hemostasis valve. Dimensions of the AXS Infinity LS Plus Long Sheath are included on the individual device label.

Stryker Neurovascular

Class I - Dangerous

A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.

Apr 18, 2019 Diagnostic Equipment Nationwide View Details →

IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

Philips North America

Class I - Dangerous

The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .

Mar 28, 2019 Diagnostic Equipment Nationwide View Details →