Potassium Chloride Injection Recalled Due to Pinhole Container Defects
B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II parenteral drug recall involves a sterility assurance failure caused by container defects. No hospitalizations or illnesses have been reported, meeting the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
B. Braun Medical Inc. is recalling Potassium Chloride for Injection Concentrate USP (500 mEq/250 mL) in 250 mL bags distributed nationwide. The recall is due to pinholes within the blue label characters on EXCEL bags that can cause leaks and compromise the sterility assurance of the product.
The recall affects 22,752 bags in two manufacturing lots: Lot #J2S007 with expiration date 12/31/2024 and Lot #J3A115 with expiration date 01/31/2025. Healthcare facilities and patients should verify lot numbers and expiration dates of any potassium chloride injection concentrates in their possession.
Persons who may have been exposed to or used a recalled bag should contact their healthcare provider. Any adverse effects related to this product should be reported to the FDA's MedWatch program. B. Braun Medical Inc. is based in Bethlehem, Pennsylvania.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Affected units
- 22,752
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 (4)
- Lot #: J2S007
- Exp: 12/31/2024
- J3A115
- Exp: 01/31/2025.
Distribution
Distributed nationwide across the United States.
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