FDA recall Z-1323-2024
Fresenius Medical Care Holdings, Inc. · Class I · device
Product
stay-safe /Safe Lock Catheter Ext. 12 in
Reason for recall
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Distribution
Domestic: Nationwide Distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-01-23
- Report date
- 2024-04-03
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1323-2024