NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Num
FDA device recall Z-1827-2015 · posted 2015-06-22 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Bacterial contamination.
- Action taken
- Fresenius Medical Care sent an Urgent Medical Device Recall letter dated May 15, 2015, to all affected customers. Users were requested to Immediately examine stock to determine whether they have any Naturalyte Liquid Bicarbonate Concentrate of the lots. " If any product of these lots is found, discontinue use immediately. " Place all units in a secure, segregated area. " If affected product was on the machine prior to patient treatment, perform a [Heat Disinfect] program. " Your dialysis schedule should not be interrupted. If interruption of your dialysis schedule is expected, please discuss your options with your health care provider. " Contact FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product. " Promptly fill out and return the attached reply form Additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com. For questions regarding this recall call 800-662-1237.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KPO
- Quantity affected
- 1,856,619 Bottles
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-05-20
- Date posted
- 2015-06-22
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB (K071387) | Fresenius Medical Care North America | 2007-06-15 |