Why it was recalled
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 25CU02007, 25CU02008, 25CU02009
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0512-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 6, 2026
- FDA report date
- May 13, 2026
- Quantity
- 37,215 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-0512-2026, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98829
- Address
- 920 Winter St Bld 920
- Code information
- Lot #: 25CU02007, 25CU02008, 25CU02009
- Postal code
- 02451-1521
- Report date
- May 13, 2026
- Product type
- Drugs
- Recall number
- D-0512-2026
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product quantity
- 37,215 bags
- Reason for recall
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 6, 2026
- Initial firm notification
- Letter
- Center classification date
- May 4, 2026