Z-0022-2013 Class II Terminated
FDA device recall Z-0022-2013 was initiated by 3M Company - Health Care Business on Sep 13, 2012 and is designated Class II. Reason for recall: 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is… The recall status is terminated (terminated Jan 29, 2013). Affected quantity: 707 units (61 US, 646 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Oct 17, 2012
- Initiation Date
- Sep 13, 2012
- Termination Date
- Jan 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 707 units (61 US, 646 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe.
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-0022-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026