FDA Recalls You Should Know About—Week of January 28, 2018

The following are a list of US Food and Drug Administration (FDA) recalls that you should know about from this week:

Panera Bread Preemptively Recalls All 2 oz. and 8 oz. Cream Cheese Products—January 28, 2018

Although no illnesses have been reported, Panera Bread has issued a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its establishments throughout the United States out of an abundance of caution. After samples of 1 variety of 2 oz. cream cheese from a single production day tested positive for Listeria monocytogenes, Panera initiated the recall. However, it is important to note that cream cheese samples tested previous to the production run in question and afterward have all come back negative.

All varieties of unexpired 2 oz. and 8 oz. cream cheese products with an expiration date on or before April 2, 2018 are included in the recall. Cream cheese sold in bakery cafes located in Canada are not included in the recall.

For more information, check out the official Company Announcement.

Kareway Products, Inc Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromise Sterility—January 29, 2018

This week, the FDA announced that Kareway Products, Inc. issues a voluntary recall for 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail, or consumer level due to potential microbial contamination.

“The product potentially could be calamitous for any population due to a probability of a potentially sight threatening eye infection or impairment,” the risk statement reads. “Kareway Products, Inc. has not received any reports of adverse events related to this recall.”

The product, packaged in 4 fluid ounce bottles, is used as an eye wash to clean and soothe eyes either for daily use or for emergency cleansing by flushing out foreign material.

For more information, check out the official Company Announcement.

Vyaire Medical Recalls AirLife Humdification Chamber & Heated Breathing Circuit Kits Due to Manufacturing Error—January 30, 2018

The FDA announced a Class I recall—which is the most serious type of recall—of Vyaire Medical’s AirLife Humidification Chamber and Heated Breathing Circuit Kits due to a manufacturing error that could potentially cause portions of the chamber to split into layers, allowing water to overflow the chamber and back up into the patient breathing circuit.

“If this occurs, an excessive amount of water could enter the airway or lungs of a ventilated patient and lead to serious adverse health consequences, including injury or death,” the announcement reads.

The kits are used with invasive and non-invasive ventilation systems to provide constant humidified breathing gasses for adults and children. The kits are typically used in hospitals as well as other health care settings under doctor supervision.

For more information, check out the official announcement.