Why it was recalled
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Product description
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
Lot numbers, UPCs & expiration codes
24AU03024, exp. date 07/31/2025
Where it was sold
Nationwide
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-0608-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 18, 2024
- FDA report date
- Jul 24, 2024
- Quantity
- 183 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
Original FDA data
Every field from FDA enforcement report D-0608-2024, exactly as published.
Show all FDA fields
- City
- Waltham
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94887
- Address
- 920 Winter St Bld 920
- Code information
- 24AU03024, exp. date 07/31/2025
- Postal code
- 02451-1521
- Report date
- Jul 24, 2024
- Product type
- Drugs
- Recall number
- D-0608-2024
- Classification
- Class II
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product quantity
- 183 cases
- Reason for recall
- This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2024