The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
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The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
Baxter Healthcare
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 for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
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 with Twist Clamp, 5C4482EJ
Baxter Healthcare
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 Escherichia coli, Staphylococcus epidermidis and S. warneri.
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.
Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
Baxter Healthcare
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.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
CURAD REUSABLE GEL HOT/COLD PACK
MEDLINE INDUSTRIES, LP - Northfield
The product contains natural rubber latex but the label states that it does not.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
Baxter Healthcare
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.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
DePuy Orthopaedics
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
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.
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.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Becton Dickinson &
May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.