Contact lenses lack sterility assurance.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Vygon MFG, Inc., dba/ Churchill Medical Systems
Class I - Dangerous
The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
Class I - Dangerous
Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.
Contact lenses lack sterility assurance.
Class I - Dangerous
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
Contact lenses lack sterility assurance.
Contact lenses lack sterility assurance.
Contact lenses lack sterility assurance.
T/Pump temperature therapy pump, Models TP700 and TP700C
Stryker Medical Division of Stryker
Class I - Dangerous
The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.
Contact lenses lack sterility assurance.
Contact lenses lack sterility assurance.
Contact lenses lack sterility assurance.
Class I - Dangerous
Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.
Contact lenses lack sterility assurance.
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Ion Beam Applications S.A.
Class I - Dangerous
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Contact lenses lack sterility assurance.
An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
Contact lenses lack sterility assurance.
Class I - Dangerous
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing.