Z-1900-2015 Class II Terminated
FDA device recall Z-1900-2015 was initiated by Covidien LLC on Apr 23, 2015 and is designated Class II. Reason for recall: Catheters may not meet antimicrobial specification The recall status is terminated (terminated Jul 26, 2017). Affected quantity: 72,363 US - 24,631 Internationally.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 8, 2015
- Initiation Date
- Apr 23, 2015
- Termination Date
- Jul 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72,363 US - 24,631 Internationally
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, 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-1900-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026