NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB
FDA device recall Z-1739-2014 · posted 2014-06-09 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Container cap may contain foreign material- 0.60% - 0.80% Manganese
- Action taken
- Fresenius Medical notified customer by letter dated 5/1/14 to examine stock immediately and instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to FMC-RTG. The customer instructed to contact the Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 12 bottles
- Distribution
- Distributed in the state of MO.
- Date initiated
- 2014-05-01
- Date posted
- 2014-06-09
- Date terminated
- 2016-06-15
- 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 |