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Open, Classified

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB

FDA Recall Z-2373-2015 · Posted 2015-08-12

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusOpen, Classified
Product CodeKPO
Date Initiated2015-07-16
Product Quantity2,264,028

Reason for Recall

Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.

Firm Action

Fresenius Medical NA issued an Urgent Expanded Medical Device Recall letter on 7/16/15 to clinics and patients. The letter identified the affected product, explained the reason for the expansion, and instructed users to immediately examine their stock to determine whether there was any Naturalyte Liquid Bicarbonate Concentrate beginning with 15AMLB, 15BMLB, 15CMLB. Users are to discontinue use immediately if any product of these lots is found, . All units are to be placed in a secure, segregated area. If affected product was on the machine prior to patient treatment, a [Heat Disinfect] program should be performed. The attached Reply Form should be completed and returned. Contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071387FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LBFresenius Medical Care North America · 2007-06-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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