FDA Recall D-1276-2014
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 526 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Reason for recall
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Recall record
- Recall number
D-1276-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide.
- Recall initiated
- 2014-02-11
- Classified by FDA Center
- 2014-04-25
- FDA published
- 2014-05-07
- Terminated
- 2015-07-22
- Recalling firm
- Baxter Healthcare Corp.
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- DIANEAL LOW CALCIUM WITH DEXTROSE
- Generic name(s)
- SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE
- Manufacturer(s)
- Vantive US Healthcare LLC
- NDC(s)
0941-0409, 0941-0411, 0941-0413, 0941-0415, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433, 0941-0484, 0941-0487, 0941-0490- Route(s)
- INTRAPERITONEAL