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FDA Medical Device Recalls (openFDA)

MRP, LLC dba AMUSA: T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

Recall number
Z-1808-2015
Recalling firm
MRP, LLC dba AMUSA
Product
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
Status
Terminated
Initiated
2015-02-09
Posted
2015-06-15
Terminated
2015-06-22
Reason
Incorrect labeling of the expiration date
Root cause
Process control
Action
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.
Quantity
1,080 units (3 cases)
Distribution
US distribution to CA only.
Lot, serial or model codes
KH04090
510(k) numbers
["K120836"]
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

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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

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