Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number:
FDA device recall Z-0681-2013 · posted 2013-01-17 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- GranuFlo Dry Acid Concentrate may show discoloration
- Action taken
- Fresenius Medical Care North America notified consignees by telephone on November 26, 2012 and follow-up letter on November 30, 2012 of the product recall. On January 10, 2013, the firm expanded there recall to an additional 32 lots (34 lots total). Customers were instructed to examine their inventory immediately, discontinue use, place all units in quarantine and return to Fresenius Medical Care North America. Customers were advised to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. For questions contact the GranuFio Recall Line at 1-888-803-0509
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 5,689 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-11-26
- Date posted
- 2013-01-17
- Date terminated
- 2016-06-21
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES (K030497) | Fresenius Medical Care | 2003-05-20 |