Z-2057-2016Class II

dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only

Name: Z-2057-2016 dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only
Creator: Dynarex Corporation
Published: 2016-03-03
License: https://open.fda.gov/license/

Dynarex Corp. / initiated 2016-03-03 / Terminated / root cause: labeling and UDI

FDA source

Dynarex Corporation began a recall of dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection on 2016-03-03. FDA classified it as Class II and gives the reason as "Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2057-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-03
Posted: 2016-06-28
Terminated: 2018-06-06
Recalling firm: Dynarex Corp.
Product: dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
Product code: NNI Container, Specimen, Non-Sterile
Reason for recall: Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On March 2, 2016, dynarex Corporate Headquarters distributed Voluntary Device Recall notices and Recall Verification Forms to their customers via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to examine their stock immediately to determine if they have any of the lots listed on hand. If so, discontinue distributing and quarantine the product immediately. Promptly contact the Dynarex Credit & Return representative Avi Celnick (845-365-8200 Ext 6644) to arrange for product return. Customers account will be credited for all returned products. All customers are advised to complete the Voluntary Recall Verification Form and returm immediately via fax or e-mail to Vijay Sachdev (Fax 845-365-8238; [email protected]).
Quantity in commerce: 399 cases/25 sleeves/20 cups & lids per sleeve
Distribution: US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
Product codes and lots: Lot Numbers: 31899, 32014, 32015, 32410 & 32411

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2057-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2057-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-27

Product code NNI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)