Sodium Chloride Irrigant
FDA Recall NDC 0990-7972
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Chloride (NDC 0990-7972). A significant event, classified as Class II, was initiated on Mar 09, 2021 by Icu Medical Inc.. The reported reason for this action was: "Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2021 Class II Recall: Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Recall Number
Class II Terminated
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Mar 09, 2021
Mar 31, 2021
425,628 bottles
Recall Profile & Regulatory Data
Event ID
87484
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
ICU Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA to include Puerto Rico
Termination Date
Sep 28, 2022
Product Description
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
Batch or Lot Expiration Information
Lot# Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
Affected Packages Involved in this Recall
0990-7138-09Product
0990-7138-36Product
0990-6138-22Product
0990-6138-03Product
0990-7972-05Product
0990-7972-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
