Z-1211-2022 Class I Ongoing
FDA device recall Z-1211-2022 was initiated by Draeger Medical, Inc. on May 16, 2022 and is designated Class I. Reason for recall: Possible occlusion of filters due to manufacturing error. The recall status is ongoing. Affected quantity: 35,950.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 22, 2022
- Initiation Date
- May 16, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,950
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NV, NY, OH, PA, TN, TX, WA, and WV. The countries of Austria, Belgium, Bulgaria, Canada, Columbia, Croatia, Czech Republic, Denmark, France, Germany, India, Indonesia, Ireland, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Malaysia, Morocco, Netherlands, Norway, Philippines, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Suriname, Sweden, Switzerland, Thailand, United Kingdom, and United Arab Emirates.
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-1211-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026