0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syrin
FDA device recall Z-1709-2015 · posted 2015-06-04 · Terminated
Recall details
- Recalling firm
- MRP, LLC dba AMUSA
- Reason for recall
- Incorrect expiration date on label
- Action taken
- The firm, AMUSA, sent a "Voluntary Recall Notification" dated 4/24/2015 to their consignees via Fed Ex on 04/27/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to return any product remaining in the distribution channel to AMUSA; check with your product representative to determine if you have any of the listed products; if any product is located, call (615) 833-2633 from 8:30 am to 5:00 pm (Eastern Time) to receive instructions as to how to return the product; follow the enclosed Steps for Voluntary Recall in their entirety, and complete and return the enclosed Product Tracking and Verification Form. Please contact your AMUSA customer service representative if you have any questions regarding this correction, any of our products, or would like assistance with the corrections. Customers can also contact the Director, Quality Assurance at 513-325-1940 or email qadirector@amusa.us.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 200,000 units
- Distribution
- US Distribution in states of:OH, PA, AL, IL, TN, and CT.
- Date initiated
- 2015-04-27
- Date posted
- 2015-06-04
- Date terminated
- 2016-05-02
- Location
- Nashville, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K133685) | Am USA | 2014-08-13 |