RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc.,
FDA device recall Z-0872-2008 · posted 2008-02-13 · Terminated
Recall details
- Recalling firm
- Rockwell Medical Technologies, Inc
- Reason for recall
- Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 33 cases (4 one gallon containers/case).
- Distribution
- Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
- Date initiated
- 2007-12-03
- Date posted
- 2008-02-13
- Date terminated
- 2008-03-31
- Location
- Grapevine, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS (K954527) | Rockwell Medical Supply | 1996-03-01 |