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ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter
LAKE FOREST, Ill., May 8, 2020 /PRNewswire/ -- ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are
About this update from Icu Medical, Inc.
[{"type":"text","content":"LAKE FOREST, Ill., May 8, 2020 /PRNewswire/ -- ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint. \n\n \n \n \n \n \n \n\n \nAdministration of a drug product that contains metal particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. To date, ICU Medical, Inc. has not received reports of adverse events related to this recall.\nLactated Ringer's Injection, USP is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. Product was distributed nationwide both by ICU Medical direct to customers and through medical distributors. The product is for human and veterinary use. \nThe affected product lot, manufactured in the U.S. for ICU Medical by Hospira, a Pfizer company in July 2019 is listed below:\nNDC Number\nProduct Description\nLot Number\nExpiration Date\nConfiguration\nManufacture Date\nDistribution Dates\n0409-7953-09\nLactated Ringer's Injection, USP\n07-514-FW\n01-Jul-2021\n1000 mL Flexible Container\nJuly 2019\nSeptember 2019 – October 2019\nICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products. Hospitals/distributors that have product that is being recalled should stop use/further distribution and return to place of purchase.\nCustomers with questions regarding this recall can call ICU Medical at 1-844-654-7780 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.\nAdverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.\nComplete and submit the report Online: www.fda.gov/medw...