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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 units make up the AquaBplus 2500Fresenius Part Number: G02040109-US AquaBplus 3000 - Typ USA G02040115-US AquaBplus 2500 - Typ USA G02040120FMC-US AquaBplus HF- Typ USA

Fresenius Medical Care Holdings

Class I - Dangerous

AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation

Mar 18, 2021 Other Medical Devices Nationwide View Details →

NM/CT 870 DR Nuclear Medicine / CT Scanners

GE Healthcare

Class I - Dangerous

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

Feb 7, 2021 Diagnostic Equipment Nationwide View Details →

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

Bard Peripheral Vascular

Class I - Dangerous

Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

Mar 25, 2021 Implants & Prosthetics Nationwide View Details →

REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Mar 16, 2021 Surgical Instruments Nationwide View Details →

VenaSeal Closure System

Medtronic

Class I - Dangerous

Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

Mar 23, 2021 Other Medical Devices Nationwide View Details →