Reported Jun 16, 2021 · Terminated
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs…
Fresenius Medical Care Holdings, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 950 · Waltham, MA · 02451-1521
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 3000 mL 2 packs (NDC 49230-0209-23) |
| 2 | 3000 mL (NDC 49230-209-30) and |
| 3 | 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451 |
- Lot codes and dates
Lot #: a) 20PU03043Exp. Date June 2022b) 20SU03036Exp. date July 2022c) 20Su07012Exp. date July 202221AU0702121AU0203721AU0100721AU0100621AU01019Exp. date August 2022
- Amount recalled
- 672 cases
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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