Z-0198-2020Class II

DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

Name: Z-0198-2020 DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
Creator: Valeritas, Incorporated
Published: 2019-07-03
License: https://open.fda.gov/license/

Valeritas, Incorporated / initiated 2019-07-03 / Terminated / root cause: manufacturing process

FDA source

Valeritas, Incorporated began a recall of DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03 on 2019-07-03. FDA classified it as Class II and gives the reason as "There is a potential for "No Needle Demo Units" to contain a needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0198-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-03
Posted: 2019-10-26
Terminated: 2020-06-24
Recalling firm: Valeritas, Incorporated
Product: DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
Product code: LZG Pump, Infusion, Insulin
Reason for recall: There is a potential for "No Needle Demo Units" to contain a needle.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 852 devices
Distribution: Nationwide within U.S.
Product codes and lots: UDI: (01)10385609021039(17)XXXXXX(10)XXXXXXXX Lot Number: DM218024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0198-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0195-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-26
Z-0196-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-26
Z-0197-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-26
Z-0198-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-26
Z-0199-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-26

Product code LZG

K103825Class IIV-Go Insulin Delivery SystemValeritas, Inc. / cleared 2011-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)