Amsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding volume.
Plain-English summary
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution. The product is a 3 mL solution in a 12 mL single-use syringe, manufactured for Hospira, Inc. The recall is due to a labeling error where the syringes may be mislabeled as containing 10 mL of solution instead of the correct 3 mL.
The affected product is identified by lot code KH03752. It was distributed to one customer in Illinois. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and facilities should check their inventory for this specific lot code and stop using the product if found. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
- Manufacturer
- Amsino Medical USA
- Category
- Medical Device — Syringes
- Hazard
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)
- KH03752
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Amsino Medical USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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