Drug Safety Alerts

Lactated Ringers Injection 1000 mL Flexible Containers Class I Recall

5/27/2020

On May 27, 2020, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of Lactated Ringer's Injection 1000 mL Flexible Containers NDC # 00409-7953-09 manufactured by ICU Medical. This recall was issued due to a confirmed customer complaint for the presence of particulate matter identified as iron oxide.

The presence of any particle mattercould be a health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot number 07-514-FW exp. 07/01/2021.

Administration 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.

Lactated 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.

Please note: This recall was issued to the hospital/user-level on May 8, 2020. In its May 27, 2020 Enforcement Report, FDA identified this as a Class I recall.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please call ICU Medical toll-free at 1-844-654-7780, Monday through Friday, 8:00 am to 5:00 pm (CT). You may also call the FDA toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.accessdata.fda.gov.