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Automated Impella Controller (AIC) with the below product descriptions and corre...
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
grand frais / fresh / mon-marché.fr - brisures de saumon fumé 150g
détection listeria monocytogenes
sans marque - spaghetti carbonara, panzerotti aux cêpes et champignons, croissan...
présence de listeria
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimul...
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed...
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-3...
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Jayco, Inc. - False Taillight Warning Light on Instrument Panel Display/FMVSS 10...
The incorrect warning light may fail to alert the driver to critical safety information or cause confusion, increasing the risk of a crash.
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, Net Wt ...
Products were made with recalled California Dairies milk powder due to Salmonella.
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS),...
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimul...
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
Undeclared Milk Allergen,
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril...
Failed Stability Specifications
Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bak...
Products were made with recalled California Dairies milk powder due to Salmonella.
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF...
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Wawa Fruit Punch Pint (16oz), Plastic bottle
Undeclared Milk Allergen,
Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle
Undeclared Milk Allergen,
Parmesan & Herb Bagel Crisps, Item Number 18139, Net Weight: 10 lbs. Legacy Ba...
Products were made with recalled California Dairies milk powder due to Salmonella.
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, la...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Basilikum gerebelt, 15 Gramm
Krankheitserreger
ARTIS Icono Ceiling, Floor and Biplane Systems
Performance