Recall Z-0875-2008 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Rockwell Medical Technologies, Inc
Dri-Sate Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-240); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
| Date | Feb 13, 2008 (initiated Dec 3, 2007) |
| Status | Terminated |
| Reason | Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old. |
| Root cause | Process control |
| Action | Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old. |
| Quantity | 10 cases (1 one quart bottle per case) |
| Distribution | Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981003 | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES International Medical Products, Inc., Jun 16, 1998 |