notyard
04-14-2009, 11:16 AM
FDA class II recall:
PRODUCT
a) SteriLyteŽ Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L). This product is used in conjunction with C-Series RenalPureŽ Liquid Acid Concentrate or DC-Series Dri-SateŽ Dry Acid Concentrate in artificial kidney (hemodialysis) machines, Recall # Z-0439-2009;
b) SteriLyteŽ Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L). This product is used in conjunction with C-Series RenalPureŽ Liquid Acid Concentrate or DC-Series Dri-SateŽ Dry Acid Concentrate in artificial kidney (hemodialysis) machines, Recall # Z-0440-2009
CODE
a) Lots: 10442, 10461 and 10462;
b) Lot: 10445
RECALLING FIRM/MANUFACTURER
Rockwell Medical Technologies, Inc., Grapevine, TX, by fax and/or email on September 29, 2008 and by letter on September 30, 2008. Firm initiated recall is ongoing.
REASON
Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
VOLUME OF PRODUCT IN COMMERCE
12,452/1 gallon containers
DISTRIBUTION
Nationwide
PRODUCT
a) SteriLyteŽ Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L). This product is used in conjunction with C-Series RenalPureŽ Liquid Acid Concentrate or DC-Series Dri-SateŽ Dry Acid Concentrate in artificial kidney (hemodialysis) machines, Recall # Z-0439-2009;
b) SteriLyteŽ Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L). This product is used in conjunction with C-Series RenalPureŽ Liquid Acid Concentrate or DC-Series Dri-SateŽ Dry Acid Concentrate in artificial kidney (hemodialysis) machines, Recall # Z-0440-2009
CODE
a) Lots: 10442, 10461 and 10462;
b) Lot: 10445
RECALLING FIRM/MANUFACTURER
Rockwell Medical Technologies, Inc., Grapevine, TX, by fax and/or email on September 29, 2008 and by letter on September 30, 2008. Firm initiated recall is ongoing.
REASON
Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
VOLUME OF PRODUCT IN COMMERCE
12,452/1 gallon containers
DISTRIBUTION
Nationwide