Z-1981-2019Class II

DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack

Name: Z-1981-2019 DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Creator: DeRoyal Industries Inc
Published: 2019-06-18
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2019-06-18 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack on 2019-06-18. FDA classified it as Class II and gives the reason as "Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of...". 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-1981-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Posted: 2019-07-16
Terminated: 2020-09-16
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Product code: LRO General Surgery Tray
Reason for recall: Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, DeRoyal, initiated the recall by "URGENT! RECALL NOTICE" letter and email on 06/18/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Using the attached Affected Products Listing, identify affected part/lot numbers in your inventory and place in quarantine to prevent further use. Please complete the Notice of Return Form and return the part/lot numbers that you have in inventory to us. You will be given credit or replacement for the returned product, whichever you prefer. 2) Complete the Affected Products Listing spreadsheet, indicating all affected products found in your inventory. PLEASE COMPLETE THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 3) Please return the completed Affected Products Listing spreadsheet and the Notice of Return Form to DeRoyal via fax to 865-362-3716 or email to [email protected] no later than July 22, 2019. 4) If you have further distributed these products, your customers must notified of this recall. You may either do this directly or notify us that you have done so, or you may provide us with your customer listing and we will contact them. 5) If you have questions or need assistance with the recall, please email: [email protected] or call 865-362-4203 or email us at [email protected].
Quantity in commerce: 108 units
Distribution: US Distribution to: OK
Product codes and lots: Lot 49888830

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1981-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1981-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)