About 500,000 additional cans of specialized medical formula manufactured by Danone’s Nutricia business will be headed to the U.S. These Neocate amino acid-based formula products--some of which are already manufactured for the U.S. market and are made at facilities in Europe--amounts to more than 5 million full-size, 8-ounce bottles. 

Date Issued: February 8, 2022

The U.S. Food and Drug Administration (FDA) is warning health care providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets. The feeding set tubing can become wrapped around a child’s neck and cause strangulation or death. The FDA has received reports of two toddlers who died after being strangled by the tubing. 

Recommendations for Parents and Caregivers of Children who Use Enteral Feeding Delivery Sets

• Be aware that the feeding set tubing can get wrapped around a child’s neck, which can lead to strangulation or death. 
• To the extent possible, avoid leaving the feeding set tubing where infants or children can become entangled.
• Discuss with your child's health care provider:
  • If your child has been tangled in their tubing before.
  • Steps you can take to help ensure that tubing does not get wrapped around your child’s neck, such as keeping the tubing away from the child as much as possible.
  • Any other concerns you may have about the risk of strangulation from feeding set tubing. 
• If your child is injured by feeding set tubing, please report the event to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Recommendations for Health Care Providers

• Review this topic and the information noted above with your colleagues, care teams, and caregivers of pediatric patients who use enteral feeding delivery sets, to ensure they are aware of the potential risk of strangulation with the associated tubing and are taking appropriate measures to keep the tubing away from the child as much as possible.
• When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety.
• If a patient experiences an adverse event related to enteral feeding set tubing, you are encouraged to report the event to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Device Description 

Enteral feeding delivery sets are medical devices used to provide nutrition to people who are unable to eat, swallow, or be fed by mouth to fully meet their nutritional needs. These sets include tubing that delivers feeding to the patient’s enteral tube (or feeding tube) using gravity or a pump. A feeding tube passes directly to the stomach or small intestine through the nose, mouth, or artificial opening in the abdomen. 

Abbott notes, "While Abbott's testing of finished product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas, powder formulas, or nutrition products from other facilities are impacted by the recall." Abbott also notes that no action is needed for previously consumed product. 

The products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after. To find out if the product you have is included in this recall, visit similacrecall.com and type in the code on the bottom of the package, or call 800-986-8540 (U.S.) and follow the instructions provided.

For more information, visit www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant

Summary

Company Announcement

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on June 23, 2020External Link Disclaimer for specified catalog numbers of the ChloraPrep™ 3 mL applicator due to possible fungal contamination, which only affects climate zone IV regions in specific U.S. territories and countries (see list of catalog numbers and regions impacted by this issue below).

BD has identified that storage of the ChloraPrep™ 3 mL Applicator in regions of the world with high heat and humidity, where product may be consistently exposed to temperatures of 30 degrees Celsius (86 degrees Fahrenheit) and 75% relative humidity for more than six months, may result in the growth of Aspergillus penicillioides. The recall does not apply to any states in the United States, it only applies to the U.S. territories of Puerto Rico, Guam, U.S. Virgin Islands, Northern Mariana Islands and American Samoa.

This recall does not include 3 mL applicators found in kits. It also does not include any other ChloraPrep™ product presentations. All other ChloraPrep™ products are manufactured with different packaging materials that are not affected by this issue.

As part of the voluntary recall to the user level, the company notified customers and distributors affected by the recall and provided guidance on the potential impact when the affected products were used.

Through internal product quality testing, BD has identified that storage of the ChloraPrep™ 3 mL Applicators where product may be consistently exposed to temperatures of 30 degrees Celsius (86 degrees Fahrenheit) and 75% relative humidity for more than six months can result in the growth of Aspergillus penicillioides, a type of fungus, resulting in a breach in the outer package integrity.

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Since patient safety is of utmost importance, all unexpired lots of these products are being recalled until a thorough investigation can be completed. There are no other related recalls for Nurse Assist products.

Click on link: http://www.fda.gov/Safety/Recalls/ucm523959.htm for more information.

U.S. Food & Drug Administration (FDA) recalls are often very significant. For example, FDA announced a recall in January of alcohol prep pads manufactured by Triad (and marketed under several brand names) due to potential microbial contamination. Several lawsuits are pending, and other products manufactured by Triad and H&P Industries are under investigation.

 

Be proactive. Have safety alerts and news of recalls delivered directly to your inbox by visiting the FDA Web site and signing up to receive their recalls and alerts. Go to www.FDA.gov and click on "Recalls and Safety Alerts” (on the right, toward the bottom). You can sign up to receive product recalls on your mobile phone, as well! On the "Recalls and Safety Alerts” page, click on "Product Recalls Mobile Phone App.” 

LifelineLetter, Mar/Apr 2011