Recall Z-2551-2011 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates
| Date | Jun 10, 2011 (initiated Mar 23, 2011) |
| Status | Terminated |
| Reason | Mislabeled: incorrect lot number printed on case labels |
| Root cause | Employee error |
| Action | 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-ba |
| Quantity | 3,190 cases |
| Distribution | Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071387 | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB Fresenius Medical Care North America, Jun 15, 2007 |