The Recall Desk
ModerateFDA (Devices)·Z-2948-2018·Announced 2018-09-05

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.

What this means for you

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.
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

Distributed nationwide across the United States.

The notice also names 27 states specifically: