Z-1396-2012

DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849

Name: Z-1396-2012 DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849
Creator: DeRoyal Industries Inc
Published: 2012-01-20
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2012-01-20 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood on 2012-01-20. The reason FDA records is "Device's needle may become dislodged from the cup during shipment or during use". 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-1396-2012
Status: Terminated
Initiated: 2012-01-20
Posted: 2012-04-12
Terminated: 2013-07-11
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849 Product Usage: Collection of cord blood
Product code: KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
Reason for recall: Device's needle may become dislodged from the cup during shipment or during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: DeRoyal Industries sent Recall communication by letter to all affected consignees of the Non-Sterile Bulk and Single Sterile Units on January 20, 2012 and of the Kits and Trays on Febraury 6, 2012. The letters identified the affected products, problem and actions to be followed. Customers were instrructed to complete the enclosed Notice of Destruction form and return this form by fax (865-362-3716) or email ([email protected]) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. Distributors were instructed to forward this recall to any of their end users that may have affected product. If you have questions or need assistance with the recall, please call 865.362.1020 or Robby Lockett at 865.362.1034.
Quantity in commerce: 2472 units
Distribution: Worldwide Distribution - USA Nationwide and the countries of: Canada, Dominican Republic, South Africa, and the United Arab Emirates.
Product codes and lots: Lot Numbers: 23383104, 24246953, 24328238, 24557401, 24797341, 24947178, 25112885, 25139279, 25373479, 25601267, 25831994, 26197358, 26634706, 26874806, 27121161, 27228507, 27467209

Product code KSR

K020753Class IIDeroyal Surgical, UmbilicupDeroyal / cleared 2002-06-13

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)