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Natpara Injection (Shire) – Delivery System Defect (2019)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class IHigh
FDASep 12, 2019Nationwide• Shire Human Genetic Therapies, Inc.
Natpara 100 mcg (Shire) – Delivery System Risk (2019)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class IHigh
FDASep 12, 2019Nationwide• Shire Human Genetic Therapies, Inc.

Stryker Corporation: Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Ou...
Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
FDASep 12, 2019PR• Stryker Corporation

Natpara 25 mcg (Shire) – Delivery System Defect (2019)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class IHigh
FDASep 12, 2019Nationwide• Shire Human Genetic Therapies, Inc.

Stryker Corporation: Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Ou...
Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
FDASep 12, 2019PR• Stryker Corporation

2018 CHEVROLET LOW CAB FORWARD 6500 Recall: ELECTRICAL SYSTEM:WIRING
Isuzu Technical Center of America, Inc. (Isuzu) is recalling certain 2017-2019 N-GAS HD and Chevrolet Low Cab Forward 3500 and 4500 vehicles and 2018-2019 Isuzu FTR and Chevrolet Low Cab Forward 6500XD vehicles. The power supply bolt in the relay box may not have been properly tightened during harness production at the supplier. This may lead to melting of the power wire and/or a loss of electrical power to the vehicle, which can lead to a stall.
NHTSASep 9, 2019Nationwide• CHEVROLET

Beckman Coulter Inc.: MicroScan WalkAway-96 plus Reconditioned Instrument
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
FDASep 4, 2019CO, FL, IL +12 more• Beckman Coulter Inc.

Beckman Coulter Inc.: MicroScan WalkAway-40 plus Reconditioned Instrument
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
FDASep 4, 2019CO, FL, IL +12 more• Beckman Coulter Inc.

Beckman Coulter Inc.: MicroScan WalkAway-40 plus Instrument
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
FDASep 4, 2019CO, FL, IL +12 more• Beckman Coulter Inc.

Beckman Coulter Inc.: MicroScan WalkAway-96 plus Instrument
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
FDASep 4, 2019CO, FL, IL +12 more• Beckman Coulter Inc.

YoCrunch Vanilla Yogurt (Danone) – Undeclared Allergens (2019)
Undeclared Nuts
Incorrect overwrap leads product to contain undeclared peanuts and eggs.
Class IIModerate
FDAAug 30, 2019AL, AZ, AR +31 more• Danone Waters of America, Inc

Pumpkin Cake Roll (Weston Foods) – Metal Contamination (2019)
Product contains lead and other pieces of metal sized .5mm -2.0mm.
Class IIModerate
FDAAug 30, 2019FL, GA, IN +2 more• WESTON FOODS (CANADA) INC

Glazed Pumpkin Cake Donut (Weston Foods) – Metal Contamination (2019)
Product contains lead and other pieces of metal sized .5mm -2.0mm.
Class IIModerate
FDAAug 30, 2019FL, GA, IN +2 more• WESTON FOODS (CANADA) INC

Publix Pumpkin Pie (Weston Foods) – Metal Contamination (2019)
Product contains lead and other pieces of metal sized .5mm -2.0mm.
Class IIModerate
FDAAug 30, 2019FL, GA, IN +2 more• WESTON FOODS (CANADA) INC

Children's Chairs and Stools (RH) – Lead Paint Violation (2019)
This recall involves Vintage Steel Play Chairs and Stools sold in distressed red under the following model names: "Play Chair", "Tall Play Chair", "Play Stool", "Tall Play Stool" and "Step Stool". The chairs have a curved, tubular back frame and a single vertical slat with an embossed seat. The stools have a curved frame and an embossed seat with a hand grip. "Made in India" and one of the following SKU numbers are printed on a green label located under the chair seat or stool step: 103480DRED (play chair); 103481DRED (tall play chair); 103521DRED (tall play stool); 103522DRED (play stool); and 111081DRED (step stool).
CPSCAug 30, 2019Nationwide

GE Healthcare, LLC: ApexPro Telemetry Server System. Also identified as Modi...
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.
FDAAug 30, 2019Nationwide• GE Healthcare, LLC

LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany: Control Panel REF - 60-02-15: LivaNova SCP Pump Control ...
The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.
FDAAug 26, 2019FL, GA, IN +10 more• LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany

LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany: Control Panel REF - 60-02-50: LivaNova SCP Pump Control ...
The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.
FDAAug 26, 2019FL, GA, IN +10 more• LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany

ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ui. Ks. Piotra Wawrzyniaka 2 Komorniki Poland: Concerto & Basic Shower Trolly, Model Numbers BAB1000-01...
The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of the arms of safety catch), which in certain circumstances may contribute to the side support unintentionally opening and may lead to a potential risk of a patient fall. The patient falling could lead to various types of injuries.
FDAAug 22, 2019CA, CO, CT +12 more• ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ui. Ks. Piotra Wawrzyniaka 2 Komorniki Poland