FDA-Device2024-04-03Class I

stay-safe /Safe Lock Catheter Ext. 12 in

Fresenius Medical Care Holdings, Inc.
Hazard

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

Sold states
Domestic: Nationwide Distribution.
Affected count
114,982 eaches
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
stay-safe /Safe Lock Catheter Ext. 12 in

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1323-2024

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