RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
All Recalls
95,075 total recalls in our database
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
RS 5F DL BIOFLO PASV, Catalog Number 60M150373
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
🏥 Medical Devices Class I - Dangerous
One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
🏥 Medical Devices Class I - Dangerous
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
🏥 Medical Devices Class I - Dangerous
When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
Maquet Cardiopulmonary Ag
🏥 Medical Devices Class I - Dangerous
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
Maquet Cardiopulmonary Ag
🏥 Medical Devices Class I - Dangerous
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
🏥 Medical Devices Class I - Dangerous
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
🏥 Medical Devices Class I - Dangerous
In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
🏥 Medical Devices Class I - Dangerous
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
RS 5F DL BIOFLO PASV, Catalog Number 60M181578
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
RS 5F DL BIOFLO PICC, Catalog Number 60M071831
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
DermaPro Waterproof Silicone Tape, SNS57232
Safe N Simple
🏥 Medical Devices Class I - Dangerous
The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
🏥 Medical Devices Class I - Dangerous
One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.