RS 5F DL BIOFLO PASV, Catalog Number 60M150373
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-003
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
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.
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
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.)
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
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.
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.
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.
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.)
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.)
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.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
DermaPro Waterproof Silicone Tape, SNS57232
Safe N Simple
Class I - Dangerous
The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
Class I - Dangerous
One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).