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Fresenius Medical Care Holdings, Inc. 2022-12-14 Health serious FDA
Health · FDA · Recall #FDA-D-0075-2023

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg,… Recall

Issued December 14, 2022 · Fresenius Medical Care Holdings, Inc.

In December 2022, Fresenius Medical Care Holdings, Inc. recalled the 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg,…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

What you should do

  1. 1 Stop using 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Fresenius Medical Care Holdings, Inc. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Fresenius Medical Care Holdings, Inc.
Category
Health
Recall date
December 14, 2022
Units affected
Not reported
Sold at
Product was distributed Nationwide in the USA.
Recall number
FDA-D-0075-2023
Made in
United States
Issuing agency
FDA

In context

  • Fresenius Medical Care Holdings, Inc. has 8 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 870th Health recall we've logged in 2022.
Read the official FDA notice

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