FDA recall Z-1371-2022

Fresenius Medical Care Holdings, Inc. · Class II · device

Product

NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2

Reason for recall

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

Distribution

Natiowide

Key facts

Status: Ongoing
Initiation date: 2022-05-31
Report date: 2022-07-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2022