D-0604-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 28, 2018
- Initiation Date
- December 20, 2017
- Termination Date
- February 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,734 cases
Product Description
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
Reason for Recall
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Distribution Pattern
Product was distributed throughout the United States to patients and clinics.
Code Information
Lot #: a) 17KU03006, 7KU03007; b) 17KU03004, 17KU03005, Exp.08/2019