The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regulation system. Failure of the peltier-element would report a system failure and no longer be able to guarantee temperature control at full power.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Argon Medical Devices
Class I - Dangerous
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Insulet
Class I - Dangerous
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
Centurion Medical Products
Class I - Dangerous
Sterile packaging incomplete seals may compromise sterility of the product
Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Thermo Fisher Scientific (Monterrey)
Class I - Dangerous
Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class I - Dangerous
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Class I - Dangerous
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Class I - Dangerous
This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.
Class I - Dangerous
ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Thoratec Switzerland GMBH
Class I - Dangerous
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T.
Potential for the Semi-Rigid canister lid to fragment during use.
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
ICU Medical
Class I - Dangerous
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class I - Dangerous
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.