Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Recall
- Recall Number
- Z-0887-2016
- Event Number
- 73077
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- FEI Number
- 3001451489
- Product Code
- KPO
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- January 18, 2016
- Posted
- February 25, 2016
- Terminated
- August 14, 2017
- Address
- 920 Winter St, Waltham, MA, 02451-1521
Description
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
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: [email protected]. 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.
US Distribution to states of: KS, LA, MS, OK, and TX.
848 (212 cases)