Device Recall Fresenius Naturalyte Liquid Acid Concentrate 의 리콜

Recall

73077

Class 2

Z-0887-2016

2016-01-18

2016-02-25

Terminated

United States

2017-08-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143014

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.

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.