ICU Medical recalls Lactated Ringer's 500mL injection due to particulate matter. This could cause serious injury if injected. Affected units have specific NDC and lot numbers.
Presence of Particulate Matter.
ICU Medical is recalling Lactated Ringer's Injection, 500 mL flexible containers because they may contain particulate matter. This could cause serious injury if the product is injected into a patient.
Particulate matter in the injection could enter the bloodstream during administration, potentially causing serious injury or death. This is a known risk with contaminated injectable products.
Healthcare professionals and patients who have received this specific Lactated Ringer's injection product. Those using the product for medical treatments are most at risk.
Check for the product name 'Lactated Ringer's Injection, USP, 500 mL flexible container', Rx Only, manufactured by ICU Medical, Inc. Look for NDC 0409-7953-03 and lot number 84-603-FW with expiration date 01 DEC 2019.
Immediately stop using the recalled Lactated Ringer's Injection product if you have it.
No, this product is recalled due to the presence of particulate matter which could cause serious injury if injected.
Stop using it immediately and contact ICU Medical for further instructions.
Check the product label for NDC 0409-7953-03 and lot number 84-603-FW with expiration date 01 DEC 2019.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall D-0349-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall D-0349-2020 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
