Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB
FDA device recall Z-2551-2011 · posted 2011-06-10 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Mislabeled: incorrect lot number printed on case labels
- Action taken
- Fresenius sent an CUSTOMER NOTIFICATION LETTER letter dated April 18, 2011, to all affected customers via Certified Mail, Return Receipt Requested. Fresenius also contacted affected customers by telephone April 18, 2011, The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to examine their stock to determine whether they have the incorrect case label and are asked to remove the correctly labeled product from the incorrectly labeled case and discard the case. Acknowledgement forms were Fax-back forms for clinics and mail-back forms (including self-addressed, stamped envelopes), for home patients. Question or concerns should be directed to Fresenius Customer Service Team at 1- 800.323.5188.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 3,190 cases
- Distribution
- Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA
- Date initiated
- 2011-03-23
- Date posted
- 2011-06-10
- Date terminated
- 2012-09-12
- 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 SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB (K071387) | Fresenius Medical Care North America | 2007-06-15 |