Terumo Needle, 18G x 1", Product Code NN1825R
FDA Recall Z-2004-2019 · Posted None
Recalling FirmTerumo Medical Corporation
Recall StatusTerminated
Product CodeFMI
Date Initiated2019-02-08
Date Terminated2020-05-08
Product Quantity810,000
Reason for Recall
There is a potential for a loss of package integrity that may compromise the sterility of the product.
Firm Action
Urgent Voluntary Medical Device Recall notification letters dated 2/8/19 were sent to customers.
Root Cause
Packaging
Distribution Pattern
The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.