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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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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