FDA Medical Device Recalls (openFDA)
MRP, LLC dba AMUSA: 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
- Recall number
- Z-1709-2015
- Recalling firm
- MRP, LLC dba AMUSA
- Product
- 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
- Status
- Terminated
- Initiated
- 2015-04-27
- Posted
- 2015-06-04
- Terminated
- 2016-05-02
- Reason
- Incorrect expiration date on label
- Root cause
- Process control
- Action
- 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.
- Quantity
- 200,000 units
- Distribution
- US Distribution in states of:OH, PA, AL, IL, TN, and CT.
- Lot, serial or model codes
- CODES: KH04103, KH04104, KH04105
- 510(k) numbers
- ["K133685"]
- PMA numbers
- not on file
- Product code
- NGT
- Firm FEI
- 1000151124
- Firm city
- Nashville
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28