Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be

FDA device recall Z-1639-2014 · posted 2014-05-22 · Open, Classified

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

Reason for recall

Naturalyte Liquid Bicarbonate maybe contaminated

Action taken

Fresenius Medical Care North America issued an Urgent Medical Device Recall Letter dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately and determine whether they have any of the affected parts on hand. If customers have the affected product, they were instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to Fresenius Medical Care Renal Therapies Group, LLC (FMC-RTG). Customers will be instructed to contact their Fresenius Medical Care Technical Services Team for instructions on how to return the recalled product. Firm will also conduct 100% telephone calls. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188. Fresenius Medical Care sent an Urgent Expanded Medical Device Recall letter on May 1, 2014 for 9 additional lots. Customers were instructed to complete and return the attached FAX BACK FORM to confirm that they have received the notice and to indicate whether or not they have the affected product in their possession. For questions regarding this recall call 800-662-1237. Firm issued Press on 5/21/14.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KPO

Quantity affected

672,784 units

Distribution

Worldwide Distribution - USA (nationwide) and Canada.

Date initiated

2014-04-10

Date posted

2014-05-22

Location

Waltham, MA

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