ICU Medical recalls AMINOSYN II 15% amino acid injection due to particulate matter found in samples. This could cause serious issues for patients receiving the injection.
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
ICU Medical is recalling AMINOSYN II 15% amino acid injection (2000 mL) because it contains fibers, hair, and protein particles. This could cause serious harm to patients receiving the injection.
The injection contains fibers, hair, and protein particles that can enter the bloodstream during administration. This poses a risk of serious injury or death for patients receiving the injection.
Patients receiving this injection under medical supervision are affected. Healthcare providers using the product for medical treatment are at highest risk.
Check for the product name 'AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL' in flexible containers. The lot number 4989094 with expiration date 01-APR-2022 is associated with this recall.
Immediately stop using the recalled AMINOSYN II 15% injection if you have it.
No, the product contains particulate matter that can cause serious harm. Do not use.
Immediately stop using it and contact your healthcare provider for alternative treatment.
Look for the product name 'AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL' in flexible containers with lot number 4989094 and expiration date 01-APR-2022.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall D-0805-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall D-0805-2021 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.
