🏥 Medical Devices Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
🏥 Medical Devices Class I - Dangerous
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
🏥 Medical Devices Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Argon Medical Devices
🏥 Medical Devices Class I - Dangerous
Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
🏥 Medical Devices Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
🏥 Medical Devices Class I - Dangerous
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
🏥 Medical Devices Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
🏥 Medical Devices Class I - Dangerous
Kits failed sterility testing and showed evidence of contamination.
🏥 Medical Devices Class I - Dangerous
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
🏥 Medical Devices Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
🏥 Medical Devices Class I - Dangerous
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
🏥 Medical Devices Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
🏥 Medical Devices Class I - Dangerous
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
🏥 Medical Devices Class I - Dangerous
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
Potential contamination with S. epidermidis E. coli and S. warneri.
🏥 Medical Devices Class I - Dangerous
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.