DELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from bag perforations that could compromise sterility. Affected patients should contact their healthcare provider immediately.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class II. The product is a sterile pharmaceutical solution for intraperitoneal dialysis, and loss of sterility assurance creates a direct risk of serious infection in a vulnerable population dependent on this medical device. This meets the Class II hospitalization-risk criterion in the rubric.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling DELFLEX Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis (2.5% dextrose, 2L, 5-pack) due to lack of assurance of sterility. The recall affects approximately 43,225 bags distributed nationwide.
The issue involves potential leaks from perforations in the bags. Affected lot numbers are 25CU02002, 25CU02011, 25CU02012, and 25CU02013.
Patients using DELFLEX from these lots should stop use and contact their healthcare provider immediately for guidance on alternative dialysis solutions and to determine if they need any medical evaluation.
The recalled product
- 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.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 43,225
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots 25CU02002
- 25CU02011
- 25CU02012
- 25CU02013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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