A potential for a light system to fall in the operating room.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
A potential for a light system to fall in the operating room.
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
A potential for a light system to fall in the operating room.
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Percussionaire
Class I - Dangerous
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
A potential for a light system to fall in the operating room.
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517
Cardinal Health 200
Class I - Dangerous
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
Cardinal Health 200
Class I - Dangerous
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Cook Medical
Class I - Dangerous
The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Greiner Bio-One North America
Class I - Dangerous
Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
Philips North America
Class I - Dangerous
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Smiths Medical Asd
Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Class I - Dangerous
Backrest platform stress fracture - the table is not operational in an inclined position
A potential for a light system to fall in the operating room.
A potential for a light system to fall in the operating room.
Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Getinge Usa Sales
Class I - Dangerous
A potential for a light system to fall in the operating room.
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Maquet Cardiovascular
Class I - Dangerous
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Calibration Serum Level 3 CAL2351
Randox Laboratories
Class I - Dangerous
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.