Month: July 2017

For Immediate Release

July 28, 2017

Contact

Consumers

ICU Medical
 1-800-441-4100

Media

Tom McCall
 tmccall@icumed.com
 949-366-4368

Announcement

ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.

Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences. Prior to administration, healthcare professionals, as instructed in the product labeling, should visually examine the product for particulate matter and discoloration and should discard if a defect is identified. The reported incident was identified prior to use, and there have been no reports of adverse events associated with this issue to date. (more…)

AccuPure floor standing filtration dispensers
Hazard:

The dispensers can overheat and smoke, posing fire and burn hazards.

Remedy:
Replace
Recall date:
July 28, 2017
Recall number:
17-760
Consumer Contact:

Nestlé Waters toll-free at 844-895-9691 from 8 a.m. to 9 p.m. ET Monday through Friday, 8 a.m. to 4 p.m. ET Saturday or online at www.readyrefresh.com and click on “Safety & Storage” at the bottom of the page for more information.

Recall Details

Description:

This recall involves Nestlé Waters AccuPure floor standing filtration dispenser with model number HB215-3G (black) and model number HW215-3G (white). They measure 44.6 inches tall by 12.5 inches wide.  The units connect to the customer location’s plumbing system, draw and filter water from the local system, and then dispense the filtered water through the unit.  The upper front panels of the units have an “AccuPure” logo and an illuminated clock display. The model number can be found on a white sticker on the back of the dispenser.

Remedy:

Consumers should immediately unplug the water dispensers and stop using them. Nestlé Waters is contacting consumers directly to schedule installation of a replacement unit. Consumers with questions should contact Nestlé Waters.

Incidents/Injuries:

Nestlé Waters has received 15 reports of overheating, including seven reports of units emitting smoke or catching fire.  No injuries have been reported. (more…)

For Immediate Release

July 27, 2017

Contact

Consumers

 by 270-434-2722

Announcement

Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may potentially be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg.

Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, which has been reported with Cyclobenzaprine HCI when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The effects of alcohol, barbiturates, and other CNS depressants may be enhanced, and may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Amantadine has a precaution in its prescribing indication about the abrupt discontinuation of the medicine. Missed doses of Amantadine in a few patients with Parkinson’s disease have experienced a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped. Apace Packaging LLC has not received any reports of adverse events related to this recall. (more…)

Name of product:
Write Again® magnetic dry erase white boards
Hazard:

The thin magnetic metal surface can separate from the product’s wooden board, posing a laceration hazard.

Remedy:
Replace
Recall date:
July 27, 2017
Recall number:
17-757
Consumer Contact:

Really Good Stuff at 800-801-4046 from 9 a.m. to 5 p.m. ET Monday through Friday, email at Recalls@reallygoodstuff.com, or online at www.reallygoodstuff.com, and click on “Product Safety” at the bottom of the page for more information.

Recall Details

In Conjunction With:
Description:

This recall includes Write Again brand dry erase white boards sold in four sizes with SKU numbers: 152277 (double sided, 9 by 12 inches ); 136110 (9 by 12 inches); 152211 (12 by 18 inches) and 301800 (6 by 9 inches).  Lot numbers XXXXXX-0903 through XXXXXX-1115 and SKU numbers are printed on a label on the back of the dry erase board.  The boards were sold individually and in packs of six.

Remedy:

Consumers should immediately stop using the recalled boards and contact Really Good Stuff for a replacement board.

Incidents/Injuries:

Really Good Stuff has received 40 reports of minor cuts. (more…)

For Immediate Release

July 26, 2017

Contact

Consumers

Grande Produce
 (888) 507-2720

Media

 (512) 848-1698

Announcement

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.

Grande Produce has announced a voluntary recall of a limited quantity of Papaya Maradol (with the brand name Caribeña labeled on cartons) distributed during the dates of July 10 and July 19 due to a potential health risk from Salmonella.

According to Grande Produce, a Maryland distribution center where the papayas were delivered has already notified retail customers to remove the recalled papayas from inventories, store shelves and the stream of commerce.  Recall effectiveness checks are already underway by Grande Produce.

The only papayas subject to the recall carry a “Caribeña” brand label on cartons and were shipped during the dates of July 10 to July 19.  No other papayas or fresh produce distributed by Grande Produce are subject to the recall.

Grande Produce has ceased importation of papayas from the grower and is taking all precautionary measures to ensure the safety of its imported produce.  The company is also coordinating closely with the U.S. Food and Drug Administration and other regulatory agencies in their investigations and will provide any assistance possible.

Environmental microbial testing conducted by Grande Produce of its facilities has been negative for the Salmonella organism to-date.   Specific sources of what health officials now believe may be two separate Salmonella outbreaks have not yet been determined.  Of the 47 cases reported nationally, five illnesses are currently reported in the State of Maryland where Grande Produce distributed product. (more…)

Class II Recall 085-2017
Health Risk: Low Jul 25, 2017

Congressional and Public Affairs
Maria Machuca
(202) 720-9113
Press@fsis.usda.gov

 

WASHINGTON, July 25, 2017 – D & D Foods, Inc., an Omaha, Neb. establishment, is recalling approximately 17,847 pounds of pepperoni pizza products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain soy lecithin, a known allergen which is not declared on the final product label.

The pepperoni pizza items were produced and packaged on various dates from April 18, 2017 to July 21, 2017. The following products are subject to recall: [View Labels (PDF Only)]

  • Cases containing four 32-oz., individually packaged pizzas of “Hy-Vee PEPPERONI PIZZA 16″ THIN CRUST” with case code of 88943.
  • Cases containing four 27-oz., individually packaged pizzas of “Hy-Vee PEPPERONI PIZZA 12″ TRADITIONAL CRUST” with case code 88901.
  • Cases containing four 47-oz., individually packaged pizzas of “Hy-Vee PEPPERONI PIZZA 16″ TRADITIONAL CRUST” with case code 88929.
  • Cases containing four 19-oz., individually packaged pizzas of “Hy-Vee PEPPERONI PIZZA 12″ THIN CRUST” with case code 88915.

The products subject to recall bear establishment number “EST. M21275” inside the USDA mark of inspection. These items were shipped to retail locations in Minneapolis.

The problem was discovered on July 22, 2017 by FSIS’ Inspection Program Personnel (IPP) while performing routine label verification activities.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. (more…)

Class I Recall 084-2017
Health Risk: High Jul 24, 2017

Congressional and Public Affairs
Maria Machuca
(202) 720-9113
Press@fsis.usda.gov

 

WASHINGTON, July 24, 2017 – Stefano’s Foods, Inc., a Charlotte, N.C. establishment, is recalling approximately 981 pounds of Stromboli products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains eggs, a known allergen which is not declared on the product label.

The frozen meatball Stromboli items, produced on June 24, 2017, were incorrectly packaged in a box labeled as pepperoni and Italian sausage Stromboli. The following product is subject to recall: [View Label (PDF Only)]

  • 18.5-oz. boxes containing two pieces of “SCREAMIN’ SICILIAN PIZZA CO. STROMBOLI SUPREMUS MAXIMUS PEPPERONI & ITALIAN SAUSAGE” with an “Enjoy by: 2/19/2018” date and lot code of 70010117517.

The products subject to recall bear establishment number “EST. 19140” inside the USDA mark of inspection. These items were shipped to a distribution center in Wisconsin.

The problem was discovered on July 21, 2017 by a company employee during the firm’s routine product packaging activities.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. (more…)

For Immediate Release

July 25, 2017

Contact

Consumers

Cantrell Drug Company
 877-666-5222

Media

Greg Turner
  greg@ballcg.com
 617-243-9950

Announcement

Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance.  The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont.  To date, Cantrell has not received any reports of adverse events. (more…)

RZR 170 recreational off-highway vehicles (ROVs)
Hazard:

The fuel tank neck can crack or the wiring harness can overheat or short circuit, posing fuel leak and fire hazards.

Remedy:
Repair
Recall date:
July 25, 2017
Recall number:
17-195
Consumer Contact:

Polaris at 800-765-2747 from 7 a.m. through 7 p.m. CT Monday through Friday, or online at www.polaris.com and click on “Off Road Safety Recalls” for more information. In addition, check your vehicle identification number (VIN) on the “Product Safety Recalls” page to see if your vehicle is included in any recalls.

Recall Details

Description:

This recall involves all model year 2015 through 2017 youth RZR 170 recreational off-highway vehicles (ROVs). The recalled ROVs have two seats and were sold in red, blue and white. For model year 2015 ROVs, “Polaris” is printed on the front grill, “RZR” is printed on the rear panel, and “170” is printed on the front panel. For model year 2016 and 2017 ROVs, “Polaris” is printed on the front grill and on the rear panel, and “RZR” is printed on the front panel. The VIN is printed on the frame on the driver’s side front wheel well.

Year Model Description
2015 R15YAV17AA RZR 170 EFI RED
2015 R15YAV17AF RZR 170 EFI BLUE
2015 R15YAV17BA RZR 170 EFI RED
2015 R15YAV17BF RZR 170 EFI BLUE
2016 Z16YAV17AB RZR 170 WHITE
2016 Z16YAV17AF RZR 170 BLUE
2016 Z16YAV1CAB RZR 170 WHITE
2016 Z16YAV1CAF RZR 170 BLUE
2017 Z17YAV17A2 RZR 170 WHITE
2017 Z17YAV17A5 RZR 170 BLUE
Remedy:

Consumers should immediately stop using the recalled ROVs and contact Polaris to schedule a free repair. Polaris is contacting all known purchasers directly.

Incidents/Injuries:

Polaris has received 102 reports of cracked fuel tank necks and 28 reports of burning, smoking, melted and/or shorted wires, including four reports of fires. No injuries have been reported. (more…)

Name of product:
LED light bulbs
Hazard:

The LED light bulb’s base can separate from the connector, posing an electrical shock hazard.

Remedy:
Repair
Recall date:
July 25, 2017
Recall number:
17-759
Consumer Contact:

R&D Products toll-free at 800-607-1848 from 8 a.m. to 5 p.m. ET Monday through Friday, via email at happytohelp@outxpro.com or online at www.outxpro.com and click on Recall Information for more information.

Recall Details

Description:

This recall involves all Outxpro 2-in-1 mosquito zapper LED light bulbs. The 10-watt bulb has a white grid housing that measures about 3.1 inches high, 3.1 inches wide and 6.1 inches deep. The grid housing has a blue light used to attract insects and an LED light below, for lighting. Item number DYT-80 and “Kinven” is printed on the product’s packaging.

Remedy:

Consumers should immediately stop using the recalled light bulbs, turn off the power supply and contact R&D Products for a free repair, including shipping, and instructions for removing and replacing the light bulb. R&D Products will reimburse consumers if a professional electrician is needed to remove the recalled light bulb’s base.

Incidents/Injuries:

The firm has received 18 reports of the bulb separating from the connector. No injuries or property damage have been reported. (more…)