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.
Plain-English summary
Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringes. The recall is due to a labeling error where the product may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
The affected product is List no. 1078-33, manufactured in Nashville, TN, for Hospira, Inc. The specific lot code is KH03752. A total of 196,400 units were distributed to one customer in Illinois.
Healthcare facilities and customers should check their inventory for this specific lot code and stop using the product if it matches the description. 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.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
- Manufacturer
- Amsino Medical USA
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 196,400
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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