Estados Unidos Recalls

POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.

Subpotent Drug

Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.

Subpotent Drug

American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H

The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.

Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.

Failed content uniformity specifications.

Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); 5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18).

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.

Storyteller Overland - Printed Circuit Board May Overheat

An overheated printed circuit board increases the risk of a fire.

Tesla, Inc. - Front Suspension Lateral Link May Separate

A lateral link separation could shift the wheel alignment, causing a loss of vehicle control and increasing the risk of a crash.

Chrysler (FCA US, LLC) - Tire Pressure Monitor System May Fail/FMVSS 138

A TPMS warning light that fails to notify the driver of low tire pressure increases the risk of a crash.

PACCAR Incorporated - Delayed Brake Timing/FMVSS 121

Delayed brake response time can increase the risk of a crash.

Chrysler (FCA US, LLC) - Rear Coil Springs May Detach

Rear coil springs that detach from the vehicle while driving increase the risk of a crash.

Chrysler (FCA US, LLC) - Rearview Camera Image May Not Display/FMVSS 111

A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.

Light Boy America,Inc - Light Tower May Detach During Towing

A detach light tower can become a road hazard for other vehicles, increasing the risk of a crash or injury.

Forest River Bus, LLC - Wheelchair Lift May Inadvertently Move

A wheelchair lift that continues to move while occupied increases the risk of injury.

Forest River, Inc. - Incorrectly Installed Furnace May Leak Carbon Monoxide

Unvented exhaust fumes increase the risk of injury from carbon monoxide poisoning.

Chrysler (FCA US, LLC) - Loss of Electronic Stability Control/FMVSS 126

A loss of electronic stability control increases the risk of a crash.

Jayco, Inc. - Incorrect Tire Size on Certification Label/FMVSS 120

Incorrect information may result in the wrong sized replacement tires being installed, increasing the risk of a crash.

Blue Bird Body Company - Wheelchair Lift May Inadvertently Move

A wheelchair lift that continues to move while occupied increases the risk of injury.

Jayco, Inc. - False Taillight Warning Light on Instrument Panel Display/FMVSS 101

The incorrect warning light may fail to alert the driver to critical safety information or cause confusion, increasing the risk of a crash.

LMSI LLC/Kofinas Olive Oil Issues a Voluntary Recall of its Garlic Mediterranean Infused Extra Virgin Olive Oil for Using a Garlic Essential Oil Not Approved for Culinary Use

Crystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs

Tiffin Motorhomes, Inc. - Propane Tanks May Detach and Missing Remote Shut Off Valve

LP tanks that cannot be shut off increase the risk of a fire. Additionally a loose LP tank may detach and become a road hazard, increasing the risk of a crash.

Northwest Naturals Voluntarily Recalls Two Raw Pet Food Products Because of Possible Salmonella & Listeria Monocytogenes Health Risk