Class I
Medical Device Recall: stay-safe /Safe Lock Catheter Ext. 12 in
Fresenius Medical Care Holdings, Inc. · January 23, 2024
Reason for Recall
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Distribution
Domestic: Nationwide Distribution.
States Affected
NATIONWIDE
Quantity Affected
114,982 eaches
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1323-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.