NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Class I - Dangerous
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Class I - Dangerous
RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.
Richard Wolf Medical Instruments
Class I - Dangerous
Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.
Class I - Dangerous
Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne
Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Richard-Allan Scientific Company
Class I - Dangerous
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Nemschoff Chairs, Inc. is recalling various model of the Serenity Treatment Chair because of potential elevated temperatures in the seat and back lumbar areas of the chair.
Class I - Dangerous
Product is not cleared for use with lasers other than the Auriga XL system
There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40.
Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Richard-Allan Scientific Company
Class I - Dangerous
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Richard-Allan Scientific Company
Class I - Dangerous
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Richard-Allan Scientific Company
Class I - Dangerous
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Richard-Allan Scientific Company
Class I - Dangerous
The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
Class I - Dangerous
Investigation determined that units supplied were missing the 4x21 degree helix angle.
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
Class I - Dangerous
Product is not cleared for use with lasers other than the Auriga XL system
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Mckesson Information Solutions
Class I - Dangerous
Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.