Recall Z-1709-2015
MRP, LLC dba AMUSA · initiated April 27, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
Codes / lots: CODES: KH04103, KH04104, KH04105
Reason for recall
Incorrect expiration date on label
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1709-2015
- Initiated
- April 27, 2015
- Posted by FDA
- June 4, 2015
- Terminated
- May 2, 2016
- Product code
- NGT – Saline, Vascular Access Flush
- Quantity
- 200,000 units
- Distribution
- US Distribution in states of:OH, PA, AL, IL, TN, and CT.
- Recalling firm
- MRP, LLC dba AMUSA, Nashville, TN