Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Di

FDA device recall Z-0887-2016 · posted 2016-02-25 · Terminated

Recall details

Recalling firm

Fresenius Medical Care Renal Therapies Group, LLC

Reason for recall

On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.

Action taken

The firm, Fresenius Medical Care, issued an "URGENT-MEDICAL DEVICE RECALL" letter dated 1/14/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your stock for the product; if found, discontinue use immediately; place all units in a secure, segregated area; contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions how to return the affected lot (lot# 15STAC072), and promptly complete and return the attached reply form by Fax to: 781-699-9796 Attn: Quality Department or scan and email to: NOTIFYRA@fmc-na.com. Fresenius will pick up and replace your product. If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-816-2309 or Website: www.fresenius-medinfo.com. Further information or support concerning this issue, contact the Customer Service Care Team at 800-323-5188 and reference the and Support Field Action Number.

Root cause

Error in labeling

Status

Terminated

Product code

KPO

Quantity affected

848 (212 cases)

Distribution

US Distribution to states of: KS, LA, MS, OK, and TX.

Date initiated

2016-01-18

Date posted

2016-02-25

Date terminated

2017-08-14

Location

Waltham, MA

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