T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only,
FDA device recall Z-1808-2015 · posted 2015-06-15 · Terminated
Recall details
- Recalling firm
- MRP, LLC dba AMUSA
- Reason for recall
- Incorrect labeling of the expiration date
- Action taken
- The firm, AMUSA, Inc., initiated the recall by telephone to the sole consignee on 02/09/2015. The consignee were informed of product, the problem and actions to be taken. The consignees verified that they were in possession of the product and that all the product has been destroyed. If you have any questions, call 513-235-1940 or email: qadirector@amusa.us.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 1,080 units (3 cases)
- Distribution
- US distribution to CA only.
- Date initiated
- 2015-02-09
- Date posted
- 2015-06-15
- Date terminated
- 2015-06-22
- Location
- Nashville, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 0.9% SODIUM CHLORIDE FLISH SYRINGE (K120836) | Am USA | 2012-07-12 |