🏥 Medical Devices • 15,809 recalls
Medtronic Sofamor Danek USA
The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.
Roche Diagnostics Operations
Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.
The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.
SCC Soft Computer
The interface fails to send abnormal flags for Reference Lab test results.
Beckman Coulter
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
Baxter Healthcare
Potential for failure of the pouch packaging seal at high altitudes.
Beckman Coulter
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
Sunrise Medical (US)
There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
The lot failed pH specification.
Beckman Coulter
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.
Sunrise Medical (US)
There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
Baxter Healthcare
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.
Beckman Coulter
N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay.