Recalls / Class III
Class IIID-0604-2021
Product
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
- Affected lot / code info
- Lot #: 20JU01001, Exp. Date February 2022
Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St Bld 950, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 25 cases
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-04-28
- FDA classified
- 2021-06-09
- Posted by FDA
- 2021-06-16
- Terminated
- 2021-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0604-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.