Skip to content
Recall Observatory FDA recall evidence

Drug product

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451

D-0605-2021

April 28, 2021

Class III

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 87907
Status
Terminated
Classification
Class III
Quantity
672 cases
Official record key
drug-enforcement:D-0605-2021

Official wording

Reason: Temperature Abuse: Product exposed to temperature outside specified limits.

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

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Temperature Abuse: Product exposed to temperature outside specified limits.