FDA recall Z-0840-2021

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

Product

Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Reason for recall

The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2020-11-23
Report date
2021-01-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0840-2021