jueves, 31 de octubre de 2019

FDA MedWatch ~ Lactated Ringer's Injection and 0.9% Sodium Chloride Injection by ICU Medical: Recall



A MedWatch Safety Alert was added to the FDA Recalls webpage. 

TOPIC: Lactated Ringer's Injection and 0.9% Sodium Chloride Injection by ICU Medical: Recall - Due to Presence of Particulate Matter

AUDIENCE: Nursing, Health Professional, Pharmacy, Risk Manager

ISSUE:  ICU Medical has recalled one single lot of Lactated Ringer's Injection and one single lot of 0.9% Sodium Chloride Injection. The products are being recalled to the hospital level due to the presence of particulate matter.  To date, ICU Medical, Inc. has not received reports of adverse events related to this recall.

The affected product lots were manufactured in late 2017 and early 2018, are listed below:

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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