FDA DrugsClass II
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange ...
Published: May 13, 2026Recall ID: D-0512-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Product Description & Identification
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Affected Products
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Additional Source Details
| Field | Value |
|---|---|
| City | Waltham |
| State | MA |
| Event id | 98829 |
| Address 1 | 920 Winter St Bld 920 |
| Code info | Lot #: 25CU02007, 25CU02008, 25CU02009 |
| Postal code | 02451-1521 |
| Report date | 20260513 |
| Product type | Drugs |
| Product quantity | 37,215 bags |
| Reason for recall | Lack of Assurance of Sterility: Potential leaks from perforations in bags. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260406 |
| Initial firm notification | Letter |
| Center classification date | 20260504 |
Overview
- Recalling FirmFresenius Medical Care Holdings, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA