ICU Medical Recalls Lactated Ringer's Injection Due to Iron Oxide Particulates
ICU Medical Inc. is recalling 93,648 units of Lactated Ringer's Injection due to confirmed iron oxide particulate matter.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
ICU Medical Inc. is recalling 93,648 flexible containers of Lactated Ringer's Injection, USP 1000 mL. The recall is being conducted because of a confirmed customer complaint regarding the presence of particulate matter identified as iron oxide.
The affected product is identified by Lot # 07-514-FW with an expiration date of 01-JUL-2021. The product was distributed nationwide within the United States.
Healthcare providers and consumers should stop using the affected product and contact ICU Medical Inc. for further instructions or a return.
The recalled product
- Product
- LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
- Manufacturer
- ICU Medical Inc
- Category
- Drug — IV Fluids
- Affected units
- 93,648
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 07-514-FW Exp. 01-JUL-2021
Distribution
Distributed nationwide across the United States.
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