Safety Report: حقن قارع الأجراس المرضعات، USP - أشار بسبب وجود الجسيمات (أكسيد الحديد), USA

United States

Company name: ICU Medical Inc.
Brand name: ICU Medical Inc.
Product recalled: Lactated Ringer’s Injection, USP
Reason of the recall: Presence of particulates (iron oxide)
FDA Recall date: May 08, 2020
Recall details: 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. 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. The affected product lot, manufactured in the U.S. for ICU Medical by Hospira, a Pfizer company in July 2019 is listed below:

- NDC Number: 0409-7953-09
- Product Description: Lactated Ringer's Injection, USP
- Lot Number: 07-514-FW
- Expiration Date: 01-Jul-2021
- Configuration: 1000 ml Flexible Container
- Manufacture Date:July 2019
- Distribution Dates: September 2019 – October 2019

ICU 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-due-presence

Source: FDA