The Recall Desk
ModerateFDA (Drugs)·D-0605-2021·Announced 2021-06-16

DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse

Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution, which may compromise sterility or safety.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall involving a temperature excursion during distribution. The source text does not report any actual illnesses, injuries, or patient harm—only a theoretical risk from exposure to out-of-specification conditions. Class III recalls are typically scored 1 or 2; the temperature-abuse nature and potential for compromised sterility in an intraperitoneal drug product justify a score of 2 (precautionary).

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling DELFLEX (Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride) Peritoneal Dialysis Solution with 2.5% Dextrose, Low Magnesium, Low Calcium. The product is supplied in 3000 mL 2-packs (NDC 49230-0209-23), 3000 mL single bags (NDC 49230-209-30), and 5000 mL bags (NDC 49230-209-50).

The recall involves 672 cases distributed nationwide in the United States. Affected lot numbers and expiration dates include: Lot #20PU03043 (June 2022), Lot #20SU03036 (July 2022), Lot #20Su07012 (July 2022), and Lots #21AU07021, #21AU02037, #21AU01007, #21AU01006, #21AU01019 (August 2022).

The product was exposed to temperatures outside the specified limits, which may compromise the integrity and safety of the solution. Patients currently using affected lots should contact their healthcare provider or Fresenius Medical Care for guidance. Healthcare providers and patients should discontinue use of affected lots immediately and consult with their healthcare professional regarding alternative dialysis solutions.

The recalled product

Product
DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
Brand
DELFLEX
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Drug — Peritoneal Dialysis Solution
Hazard
Affected units
672

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 (11)

  • Lot #: a) 20PU03043
  • Exp. Date June 2022
  • b) 20SU03036
  • Exp. date July 2022
  • c) 20Su07012
  • 21AU07021
  • 21AU02037
  • 21AU01007
  • 21AU01006
  • 21AU01019
  • Exp. date August 2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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.

See all 8 products in this recall →

Related recalls

Same brand · DELFLEX

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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Same hazard · temperature abuse

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