CLASS III Device recall · Reported 26 Sep 2012 · FDA Enforcement Report
0.9% Sodium Chloride Injection recalled by Amsino Medical U
Amsino Medical U is recalling 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution in Single Use Syringe, distributed in Illinois. The recall was initiated on 15 Aug 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2394-2012
- FDA event ID
- 63105
- Recalling firm
- Amsino Medical U, Nashville, TN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Aug 2012
- FDA classified
- 15 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Syringes & Needles
Timeline
| 15 Aug 2012 | Recall initiated by company | |
| 15 Sep 2012 | Classified by FDA | +31 days |
| 26 Sep 2012 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
Product as listed by the FDA
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.
Where it was distributed
Distributed to one customer in Illinois.
Questions about this recall
Why was it recalled?
One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
Which lots are affected?
KH03752
Where was it sold?
Distributed to one customer in Illinois.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 63105| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | 0.9% Sodium Chloride Injection recalled by Amsino Medical U | Amsino Medical U | Labeling Errors | IL |
More recalls from Amsino Medical U
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | 0.9% Sodium Chloride Injection recalled by Amsino Medical U | Amsino Medical U | Labeling Errors | IL |
Other Syringes & Needles recalls
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|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |