Class I

Medical Device Recall: stay-safe /Luer Lock Catheter Ext. 18 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

479,978 eaches

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1326-2024

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.