Category: Enterobacter sakazakii

Profiling Cronobacter sakazakii (Enterobacter sakazakii)

Cronobacter sakazakii (formerly known as Enterobacter sakazakii) is a rare, though often fatal, cause of meningitis in newborns and infants.

Some history

Cronobacter sakazakii has gone through more than one name change. It was first described as a yellow-pigmented Enterobacter cloacae, then – in 1980 – assigned the species name Enterobacter sakazakii (Farmer, J.J. III, et al. 1980. Enterobacter sakazakii: A new species of “Enterobacteriaceae” isolated from clinical specimens. Internat. J. Systemic Bacteriol. 30(3): 569-584). The pathogen was linked to cases of neonatal meningitis for the first time in 1961 in a British report (Urmenyi, AM & Franklin, AW. 1961. Neonatal death from pigmented coliform infection. Lancet 1(7172): 313-315), and for the second time in a 1965 report from Denmark (Joker, R.N., et al. 1965. A case of neonatal meningitis caused by a yellow enterobacter. Dan. Med. Bull. 12:128-130).

What is Cronobacter sakazakii, and where is its natural habitat?

Cronobacter sakazakii is an opportunistic pathogen, affecting mainly newborns, and causes neonatal necrotizing enterocolitis and neonatal meningitis. In older infants, children and adults, it can cause sepsis and/or respiratory illness. The microbe has been found in many countries around the world, and has been recovered from Mexican fruit flies and the larvae of stable flies. It is found in food production facilities and households, and has been detected at low levels in powdered infant formulas in a number of countries.

How is Cronobacter sakazakii transmitted? What is the incubation period of the infection?

Cronobacter sakazakii infections of newborns have been traced to the use of reconstituted powdered infant formula, especially in hospital settings where formula is prepared in bulk and stored for several hours under refrigeration until needed. In neonatal intensive care units (NICU), feedings can take several hours, during which time the reconstituted formula remains at room temperature – a recipe for microbial multiplication. The incubation period for a Cronobacter sakazakii infection may be as short as one day or as long as three weeks; typically, infections show themselves within one week.

What illnesses are caused by Cronobacter sakazakii? How long does it take to develop?

Cronobacter sakazakii is a cause of necrotizing enterocolitis and meningitis in newborns. In older babies, children and adults, this opportunistic pathogen can cause respiratory infections and sepsis.

What are the symptoms of Cronobacter sakazakii infections?

Symptoms in newborns include fever, rapid heart rate, seizures and other neurological abnormalities.

What is the prognosis of Cronobacter sakazakii infections?

Cronobacter sakazakii infections are often fatal in newborns. The death rate has been reported to be as high as 40-80%.

What foods carry Cronobacter sakazakii?

Cronobacter sakazakii has been found at low levels in powdered infant formulas. It also can be found in water and the environment.

How can susceptible people protect themselves from infection?

The Illinois Department of Public Health offers the following advice:

Clean utensils

  • Wash hands, forearms and fingernails thoroughly before handling any feeding materials or preparing formula.
  • All bottles, nipples, caps and rings should be washed in hot, soapy water with thorough rinsing.

Preparing formula

  • Before use, powdered formula should be kept dry in an airtight container with a firm cap or lid and stored in a cool, dark area. Make sure the expiration date has not passed.
  • During formula preparation, bring water to a bubbling boil for two minutes and allow the water to cool before mixing.
  • Do not use a microwave oven to warm the formula.

Storing formula

  • Formula should be prepared in small amounts immediately before feeding time to minimize the need for storing reconstituted formula.
  • Reconstituted formula should not be stored at room temperature for more than one hour or more than four hours in the refrigerator after preparation.
  • Throw out any formula left in a bottle after feeding.

You can find more information on Cronobacter sakazakii and other food-borne pathogens in Food Safety: Old Habits, New Perspectives.

Missouri Baby Dead: Is Infant Formula To Blame?

FDA, CDC, and health officials in Missouri and Illinois are investigating at least two cases of Cronobacter sakazakii (once known as Enterobacter sakazakii) – a rare, but often fatal, cause of meningitis that most often affects newborn babies.

Two Missouri infants have died – 10-day old Avery Cornett of Lebanon, and a one-month old baby girl in Granite City – and an Illinois infant is recovering from the infection.

At least one of the three infected babies is known to have been fed Enfamil Newborn Formula (12.5-oz cans; Lot #ZP1K7G), a product of Mead Johnson Nutrition.

Mead Johnson Nutrition released the following statement yesterday:

December 22, 2011

Our company recently became aware of an infant’s death in Missouri. This infant tested positive for Cronobacter, which is a microorganism commonly found in the environment and sometimes implicated in rare but serious illnesses in newborn babies. We were informed that the infant had been fed one of our products.

The product – Enfamil PREMIUM® Newborn powdered formula – has not been recalled, but is being tested by the U.S. Food and Drug Administration (FDA) with our assistance. All of our finished infant powdered products (including this batch) are tested for Cronobacter (Enterobacter sakazakii) prior to shipment. If an ingredient or a batch of powdered infant formula product is found to contain Cronobacter, it is rejected and not distributed.

The batch of the product used by the child’s family did not show the presence of the bacteria when it was produced and packaged, and that has recently been reconfirmed from our batch records. This product is not being recalled – nor is any other Mead Johnson product – but some retailers are removing it from their shelves as a precautionary measure. The product is Enfamil PREMIUM Newborn 12.5 ounce powder with number ZP1K7G on the bottom of the can.

We recognize that recent media stories may cause confusion and we apologize for that. We want to make every effort to keep our customers informed on any topics related to our products.

We are working with health authorities to support their efforts to identify the source or cause of the infant’s infection. All the employees at Mead Johnson Nutrition wish to extend our heartfelt sympathy to the family.

If you have any questions please contact us at 1-800-BABY-123.

Although the investigation is still in progress and Mead Johnson has not recalled the powdered baby formula, a number of retailers, including Walmart and Price Chopper, have removed the suspect product from store shelves until FDA and CDC complete their studies.

This is not Mead Johnson’s first brush with Cronobacter (formerly Enterobacter) sakazakii. In 2001, a hospital outbreak of Enterobacter sakazakii was traced to a contaminated batch of Portagen powdered infant formula, used to feed babies in the neonatal intensive care unit of a Tennessee hospital. The investigation into the causes of that outbreak led to changes in FDA’s recommendations for the preparation, use, and storage of reconstituted powdered infant formula.

FDA has collected – and is in the process of analyzing – several samples of the infant formula and the water used to reconstitute the formula from the Lebanon, Missouri and the Illinois cases, according to FDA Spokesperson Siobhan DeLancey.

“This is a tragic case,” DeLancey said, “and we are working as quickly as possible to investigate all the avenues by which the baby could have been infected.”

“It is important to note,” DeLancey adds, “that at this time there is no confirmation that either infant’s infection was caused by the infant formula or the water used to reconstitute it.”

FDA estimates that its test results will be completed by the middle or latter part of next week. And I’m told by CDC’s Lola Russell that genetic profiles (PFGE profiles) of the bacteria recovered from the infected babies also may be available next week. CDC expects that the complete investigation, including environmental test results, could take up to one month.

The Illinois Department of Public Health has issued the following recommendations to consumers who use powdered infant formula:

Clean utensils

  • Wash hands, forearms and fingernails thoroughly before handling any feeding materials or preparing formula.
  • All bottles, nipples, caps and rings should be washed in hot, soapy water with thorough rinsing.

Preparing formula

  • Before use, powdered formula should be kept dry in an airtight container with a firm cap or lid and stored in a cool, dark area. Make sure the expiration date has not passed.
  • During formula preparation, bring water to a bubbling boil for two minutes and allow the water to cool before mixing.
  • Do not use a microwave oven to warm the formula.

Storing formula

  • Formula should be prepared in small amounts immediately before feeding time to minimize the need for storing reconstituted formula.
  • Reconstituted formula should not be stored at room temperature for more than one hour or more than four hours in the refrigerator after preparation.
  • Throw out any formula left in a bottle after feeding.

Readers can find more information on Cronobacter (Enterobacter) sakazakii – including its connection with powdered infant formula and meningitis in infants – in my book, Food Safety: Old Habits, New Perspectives, published in 2007 by ASM Press.

Recalls and Alerts: December 22, 2011

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

  • Allergy Alert: Market Basket recalls Market Basket Solid White Albacore Tuna in Water (5oz; Best buy dates of August 18, 2014 and August 19, 2014), due to the presence of undeclared soy. The product was sold only at Market Basket stores in Massachusetts and New Hampshire.
  • Food Safety Recall: Starwest Botanicals (Rancho Cordova, CA) recalls Starwest Organic Whole Celery Seed (2-oz, Lot #F7073; 1-lb, Lot #40203), because the product may be contaminated with Salmonella. The recalled product was sold between April 26, 2011 and December 14, 2011.
  • Food Safety Recall: Cal Fresco, LLC recalls fresh Jalapeño (Lot #205610) and Serrano (Lot #205467) chili peppers that may be contaminated with Salmonella. The Jalapeño peppers were shipped in cases under the Cal Fresco and Grower Alliance labels to retail stores within California, Oregon, Washington, Texas and Canada between December 3 and December 5, 2011. The Serrano peppers were shipped to retailers in Canada (Edmonton, Winnipeg and Vancouver), Southern California, Alaska, Washington and Texas (Dallas). Both products originated in Mexico.
  • Dietary Supplement Safety Recall: Eclectic Institute (Sandy, OR) recalls various freeze-dried capsules containing Gotu Kola and Bladderwrack, because of potential Salmonella contamination. Please refer to the recall notice for complete details of affected products, including lot numbers and dates of sale.
  • FDA Warning Letter: FDA warns The Cake Box, Inc. (Lafayette, CA) that a September 2011 inspection of the company’s bakery documented serious violations of the Current Good Manufacturing Practice regulation for foods. Violations included lack of effective pest control and insanitary conditions.
  • FDA Warning Letter: FDA warns Global Sweet Polyols, LLC (Rehoboth, MA) that a May/June 2011 inspection of the company’s dietary supplement facility revealed failure to comply with the requirements of the Current Good Manufacturing Practice regulations for dietary supplements.
  • FDA Warning Letter: FDA warns Golden Temple of Oregon, LLC (Portland, OR) that a May 2011 inspection of the company’s facility revealed significant violations of the Current Good Manufacturing Practice regulations for dietary supplements.
  • Outbreak Alert/Product “Pull”: Walmart has pulled a single production batch of  Enfamil Newborn infant formula (a Mead Johnson Nutrition brand) from its stores nationwide after the death of a Lebanon, Missouri infant, according to media reports. The infant died from Cronobacter sakazakii (previously known as Enterobacter sakazakii), a rare and often fatal bacterium that occasionally contaminates powdered infant formula.
  • OTC Pharmaceutical Product Recall: McNeil Consumer Healthcare recalls from retailers certain lots of Motrin® IB 24-count Coated Caplets (Lot #ACA310, ACA460, ADA407 AEA262, AFA226, AJA170 ALA037, ALA163, AMA012 AMA331, AMA342, APA035 ASA082, ASA123, ASA285 BDA238, BDA260, BDA383 BEA065, BEA148, BEA269 BEA277, BFA064, BFA144 BFA244, BHA078, BHA147 BHA167, BHA198, BJA164 BJA221, BMA144, BMA215 BMA271, BSA022, BSA056 CBA063, CBA107, CCA028 CDA003, CFA065, CFA100 CHA012, CHA044, CHA066 CHA080, CMA028, CMA035 CMA057, CMA102, and CMA108), Motrin® IB 24-count Coated Tablets (Lot #ADA069, ALA168, ALA244 AMA286, APA001, and ASA001) and Motrin® 24+6 count Coated Caplets (Lot #ACA761 and ALA265), because testing product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer-level recall. The recalled products were distributed in United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.
  • Consumer Product Safety Recall: Target Corporation (Minneapolis, MN) recalls Circo Childrens’ 17″ Travel Cases (Cate codes 01/11 through 08/11) because the surface coating on the travel cases contains excessive levels of lead.

Canada

  • Allergy Alert: Uruthira Brothers Ltd. recalls MD brand Lime Cordial (750mL), Passion Fruit Cordial (750mL), Mango Cordial (750mL), Garlic Paste (250g), and Ginger Paste (225g and 350g), due to the presence of undeclared sulphites. The recalled products were distributed to retailers in Alberta, British Columbia, Ontario and Quebec.
  • Food Safety Recall: Maple Crisp Orchards Maple Products recalls Maple Crisp Orchards 100% Pure Pasteurized Apple Cider (2L and 4L; Processed Nov 3/11), due to the presence of patulin, a toxin produced during the growth of certain molds.
  • Food Safety Recall Update: Canada Safeway Ltd. (Calgary, AB) recalls Fresh Serrano Peppers (Product of Mexico, imported from the USA; unlabeled from bulk; sold between December 5 and 20, 2011 inclusive), because the product may be contaminated with Salmonella. The recalled Serrano peppers were sold from bulk at Safeway stores and various independent grocery stores in Alberta, British Columbia, Manitoba, Northwest Territories, Ontario, Saskatchewan and Yukon.
  • Consumer Product Safety Recall: Distributions (Daniel Coderre), Inc., Arden Holdings Inc., Groupe Dynamite Inc., John Bead Corporation Ltd., Bizou International, Frabels Inc., and DeeJay Jewellery Inc. recall various childrens’ trinkets (including necklaces and charms), due to excessive levels of lead and/or cadmium. Please navigate to the individual recall notices for details on the recalled items.

Europe

Asia, Africa and the Pacific Islands

  • Consumer Product Safety Alert (Philippines): Several types of beverage and food containers sold in the market in Metro Manila have been found to contain high levels of antimony, arsenic, cadmium, chromium and lead, according to a survey carried out by the EcoWaste Coalition.
  • Outbreak Alert (Hong Kong): The Centre for Health Protection is investigating a suspected food poisoning outbreak involving 21 people following a workplace Christmas party. The 3 males and 18 females developed abdominal pain, diarrhea and vomiting approximately 9 to 49 hours after sharing a lunch on December 17. One person required hospitalization.
  • OTC Pharmaceutical Product Recall (Fiji): McNeil Consumer Healthcare recalls from retailers certain lots of Motrin® IB 24-count Coated Caplets (Lot #ACA310, ACA460, ADA407 AEA262, AFA226, AJA170 ALA037, ALA163, AMA012 AMA331, AMA342, APA035 ASA082, ASA123, ASA285 BDA238, BDA260, BDA383 BEA065, BEA148, BEA269 BEA277, BFA064, BFA144 BFA244, BHA078, BHA147 BHA167, BHA198, BJA164 BJA221, BMA144, BMA215 BMA271, BSA022, BSA056 CBA063, CBA107, CCA028 CDA003, CFA065, CFA100 CHA012, CHA044, CHA066 CHA080, CMA028, CMA035 CMA057, CMA102, and CMA108), Motrin® IB 24-count Coated Tablets (Lot #ADA069, ALA168, ALA244 AMA286, APA001, and ASA001) and Motrin® 24+6 count Coated Caplets (Lot #ACA761 and ALA265), because testing product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer-level recall. The recalled products were distributed in United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.
  • Pharmaceutical Product Safety Recall (Hong Kong): B. Braun Medical (H.K.) Limited recalls three Nutriflex Lipid products manufactured in Germany by B. Braun Melsungen AG, because stability testing on the above products had identified potential particulate formation over time.
  • Dietary Supplement Safety Alert (Hong Kong): The Department of Health urges the public not to purchase or use a slimming product identified as 之素囊, as the product may contain the banned ingredients sibutramine, phenolphthalein, fenfluramine and animal thyroid tissue. The product was purchased on the Mainland.
  • Dietary Supplement Safety Alert (Hong Kong): The Department of Health urges the public not to purchase or use Jin Yu Tang Tai Han Kang Pai Pu Ling Jiao Nang, because it was found to contain the undeclared western drugs metformin, rosiglitazone, glibenclamide and phenolphthalein.
  • Outbreak Alert (Hong Kong): The Centre of Health Protection is investigating a confirmed case of listeriosis involving a 32-year old pregnant woman. The baby passed away one day after birth. The woman is in stable condition.

Australia and New Zealand

  • Allergy Alert (Australia): Anchor Foods Pty Ltd. recalls Spencers Cocoa Powder (500g cellophane sachet; all best before dates between 1 JUL 2013 to 5 OCT 2013), IGA Signature Chocolate Cake Mix (500g cardboard packet; Best before 22 NOV 2012 and 12 DEC 2012), IGA Signature Fudge Brownie Mix (500g cardboard packet; Best before 21 AUG 2012 and 21 NOV 2012) and IGA Signature Chocolate Baby Cake Mix (300g cardboard packet; Best before 29 NOV 2012 and 15 Dec 2012), due to the presence of undeclared sesame. The recalled products were manufactured in Australia, using cocoa imported from China.
  • Diet Pill Safety Alert (Australia): The Therapeutic Goods Administration warns consumers that Lipro Diet Pills, which are labeled as 100% herbal, contain the undeclared prescription substance sibutramine. Taking Lipro Diet Pills for weight loss posses a serious health risk. Commercial supply of this product is illegal in Australia; however, it is available through the Internet.

Latin America and the Caribbean

  • Food Safety Notification (EU #2011.1883): Salmonella in ground cumin from the United Kingdom, with raw material from Syria; distributed to Gibraltar, Netherlands Antilles, Poland, Sweden and the United Kingdom. The ground cumin is sold under the Natco Foods brand (100g jar, 100g pack, 400g pack, 1kg pack and 5kg pack), and carries Best before dates of September 2013 and October 2013.
  • OTC Pharmaceutical Product Recall (several Caribbean countries): McNeil Consumer Healthcare recalls from retailers certain lots of Motrin® IB 24-count Coated Caplets (Lot #ACA310, ACA460, ADA407 AEA262, AFA226, AJA170 ALA037, ALA163, AMA012 AMA331, AMA342, APA035 ASA082, ASA123, ASA285 BDA238, BDA260, BDA383 BEA065, BEA148, BEA269 BEA277, BFA064, BFA144 BFA244, BHA078, BHA147 BHA167, BHA198, BJA164 BJA221, BMA144, BMA215 BMA271, BSA022, BSA056 CBA063, CBA107, CCA028 CDA003, CFA065, CFA100 CHA012, CHA044, CHA066 CHA080, CMA028, CMA035 CMA057, CMA102, and CMA108), Motrin® IB 24-count Coated Tablets (Lot #ADA069, ALA168, ALA244 AMA286, APA001, and ASA001) and Motrin® 24+6 count Coated Caplets (Lot #ACA761 and ALA265), because testing product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date. This is not a consumer-level recall. The recalled products were distributed in United States, Puerto Rico, Bahamas, Fiji, Belize, St. Lucia and Jamaica.
Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.
*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.