Z-2679-2016Class II

DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O

Name: Z-2679-2016 DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O
Creator: DeRoyal Industries Inc
Published: 2016-08-11
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2016-08-11 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O on 2016-08-11. FDA classified it as Class II and gives the reason as "The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible...". 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-2679-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-11
Posted: 2016-08-26
Terminated: 2017-06-13
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
Product code: LRO General Surgery Tray
Reason for recall: The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DeRoyal issued their recall on 08/11/2016 to the end-user level by sending overnight letters to its direct accounts. The customers were asked to identify the affected trays, place them in quarantine and return them to DeRoyal for replacement or credit.
Quantity in commerce: 24 units
Distribution: Distributed in LA and TN.
Product codes and lots: Lot Number 40004006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2679-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2678-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26
Z-2679-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)