Drug product
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
D-0513-2026
Product summary
- Event
- Event 98829
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43,225 bags
- Official record key
drug-enforcement:D-0513-2026
Official wording
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Code information: Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility