Z-0993-2022 Class II Ongoing
FDA device recall Z-0993-2022 was initiated by Baxter Healthcare Corporation on Mar 15, 2022 and is designated Class II. Reason for recall: This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return… The recall status is ongoing. Affected quantity: 3513 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- Mar 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3513 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0993-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026