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Class I: serious health riskTerminated

ICU Medical LACTATED RINGER'S Injection Recall

LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc

ICU Medical Inc · Lake Forest, IL

Risk level
Class I
Reported by FDA
May 27, 2020
Recall ID
D-1270-2020
Check your lot numberHow we source this data

Summary

ICU Medical recalled LACTATED RINGER'S Injection starting May 8, 2020. The FDA classified it as Class I (serious health risk) and published enforcement report D-1270-2020 on May 27, 2020. Reason: Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide. Status: Terminated.

Why it was recalled

Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.

Product description

LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

Lot numbers, UPCs & expiration codes

Lot #: 07-514-FW Exp. 01-JUL-2021

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1270-2020
Classification
Class I
Status
Terminated
Recall initiated
May 8, 2020
FDA report date
May 27, 2020
Quantity
93,648 flexible container
Recall type
Voluntary: Firm initiated
Recalling firm
ICU Medical Inc

Original FDA data

Every field from FDA enforcement report D-1270-2020, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
85625
Address
600 N Field Dr
Code information
Lot #: 07-514-FW Exp. 01-JUL-2021
Postal code
60045-4835
Report date
May 27, 2020
Product type
Drugs
Recall number
D-1270-2020
Classification
Class I
Recalling firm
ICU Medical Inc
Product quantity
93,648 flexible container
Termination date
Nov 10, 2021
Reason for recall
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Voluntary / mandated
Voluntary: Firm initiated
Product description
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Distribution pattern
Nationwide within the United States
Recall initiation date
May 8, 2020
Initial firm notification
Press Release
Center classification date
May 19, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1270-2020, published May 27, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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