DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
FDA Recall Z-0199-2020 · Posted None
Recalling FirmValeritas, Incorporated
Recall StatusTerminated
Product CodeLZG
Date Initiated2019-07-03
Date Terminated2020-06-24
Product Quantity60 devices
Reason for Recall
There is a potential for "No Needle Demo Units" to contain a needle.
Firm Action
On July 3, 2019, Valeritas issued notices to customers via first class U.S. postal service. The removal strategy is to notify active HCP office accounts from the manufacturing start date of effected product (January 2018) who may have No Needle Demo units in their possession. The removal letter instructs HCP offices to dispose of any No Needle Demo product on hand and acknowledgement by signing and returning the removal letter as instructed.
Root Cause
Employee error
Distribution Pattern
Nationwide within U.S.
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.