Medline Sodium Chloride Injection Recalled for Incorrect Overwrap Packaging
Medline Industries is recalling 90,870 units of 0.9% Sodium Chloride Injection due to incorrect overwrap packaging. The product is intended for flushing IV catheters and tubing.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a packaging defect (incorrect overwrap) without reported injuries or illnesses, fitting the criteria for moderate severity involving minor labeling or packaging errors.
Plain-English summary
Medline Industries Inc is recalling 90,870 units of Medline 0.9 % Sodium Chloride Injection, USP, 5 mL in 10 mL Syringe ZR. The recall was initiated because the product was packaged with an incorrect overwrap. This medical device is intended for flushing IV catheters and IV tubing only.
The affected units were distributed nationwide to the following states: CA, CT, DE, FL, GA, IN, LA, MA, MD, MN, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, and WV. The specific lot number for the recalled product is 3131591.
Healthcare facilities and consumers should stop using the affected product and contact Medline Industries Inc for further instructions or a return. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — IV Supplies
- Hazard
- Affected units
- 90,870
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 (1)
- Lot # 3131591
Distribution
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