ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling
- Date
- Feb 13, 2025
- Company
- ICU Medical
- Brand
- ICU Medical
- Product
- POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq
- Reason
- Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq.
- Hazard
- Other
- Source
- FDA
How to identify the product
- FOR IMMEDIATE RELEASE – February 13, 2025 LAKE FOREST, Illinois – ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level.
- ICU Medical has identified a potential for some of the product overwraps in one lot being mislabeled as 10 mEq (instead of 20 mEq that is contained in the I.V.
- The lot 1023172 and Exp.
- These mislabeled bags are packaged in cases labeled: NDC 0990-7075-26, CASE PACK 1x24 – 100ML 20MEQ POTASSIUM CHLORIDE INJECTION LOT NO. 1023172, EXP DATE 2026-01.
- ICU Medical is notifying its customers, including distributors, of this recall by letter, and is arranging for the return of all recalled product.
- All Health Care professionals that have product that is being recalled should stop use/further distribution, as applicable, and return to place of purchase.
Where to find the lot number or date code on your package →
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.