High FDA (Drugs)·D-0015-2023·Announced 2022-10-26

Saline Solution Injection Recalled Nationwide Due to Sterility and Leakage

Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection distributed nationwide due to lack of assurance of sterility and potential leakage. Multiple lot numbers with expiration dates ranging from May 2023 to August 2023 are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with lack of sterility assurance and potential leakage. While the hazard poses significant risk of infection for injectable solutions, no illnesses or injuries have been reported. Per the severity rubric, this qualifies as a high-risk situation where injury has not yet been reported.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 0.9% Sodium Chloride Injection, USP, a sterile injectable saline solution distributed nationwide. The product is supplied in 1-liter bags, packaged in cases of 12 bags each. The recall affects approximately 16,006 cases.

The recall is being issued due to lack of assurance of sterility and potential leakage of the product. The affected lot numbers include 22EU05043 (expiration 5/21/2023), 22HU05018 (6/9/2023), 22HU05019 (6/10/2023), 22HU05025 (6/12/2023), 22HU05026 (6/12/2023), 22HU05049 (6/22/2023), 22HU05053 (6/24/2023), 22HU05054 (6/25/2023), 22HU05055 (6/25/2023), 22HU06027 (6/11/2023), 22HU06049 (6/23/2023), 22HU06055 (6/24/2023), 22HU06056 (6/25/2023), 22JU05008 (7/4/2023), 22KU06036 (8/19/2023), and 22JU06023 (7/8/2023).

The product was distributed nationwide in the USA. Healthcare facilities and providers who have received this product should verify they do not possess the affected lot numbers and should not use the product if the lot number matches one of the recalled batches.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Drug — Injectable / IV Solution
Hazard: lack-of-sterility
leakage
Affected units: 16,006

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot # 22EU05043
EXP 5/21/2023
22HU05018
EXP 6/9/2023
22HU05019
EXP 6/10/2023
22HU05025
22HU05026
EXP 6/12/2023
22HU05049
EXP 6/22/2023
22HU05053
EXP 6/24/2023
22HU05054
22HU05055
EXP 6/25/2023
22HU06027
EXP 6/11/2023
22HU06049
EXP 6/23/2023

Distribution

Distributed nationwide across the United States.

Same brand · SODIUM CHLORIDE

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