Z-2364-2015Class II

Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212

Name: Z-2364-2015 Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
Creator: Cadence Inc.
Published: 2015-07-09
License: https://open.fda.gov/license/

Cadence Inc. / initiated 2015-07-09 / Terminated / root cause: design

FDA source

Cadence Inc. began a recall of Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212 on 2015-07-09. FDA classified it as Class II and gives the reason as "Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2364-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-09
Posted: 2015-08-10
Terminated: 2016-07-29
Recalling firm: Cadence Inc.
Product: Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
Product code: GAA Needle, Aspiration And Injection, Disposable
Reason for recall: Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Root cause tag: design
FDA root cause: Device Design
Action: Cadence issued the recall letter, specific to the customer dated 7/9/15 via registered mail on July 17, 2015. Accounts are requested to Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Contact Cadence Science, Inc. using the Response Form provided. 4. If this information is received by a dealer, wholesaler, or distributor/reseller that distributed any of these products to other facilities, then notify their customers of this action so that those customers can locate and remove all affected products. Any questions contact: Phone: 401-942-1031
Quantity in commerce: 766 units
Distribution: Nationwide Foreign Canada, Denmark. Italy
Product codes and lots: Packged Lots: Catalog Number 5202: 79713-04, 80468-05, W003542/1, W006324/1, W006324/2, W006324/3, W006324/4, W006324/5; Catalog Number 5205: 79748-03; Catalog Number 5212: W008136/1, W008686/1, W011240/1, W010905/1, W012135/1, W014053/1, W015838/1, W011240

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2364-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2364-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-10
Z-2365-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-10

Product code GAA

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)