Z-0927-2023Class II

DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

Name: Z-0927-2023 DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Creator: DeRoyal Industries Inc
Published: 2022-12-12
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2022-12-12 / Terminated / root cause: packaging

FDA source

DeRoyal Industries Inc began a recall of DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 on 2022-12-12. FDA classified it as Class II and gives the reason as "DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0927-2023
Classification: Class II
Status: Terminated
Initiated: 2022-12-12
Posted: 2023-01-09
Terminated: 2026-05-29
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Product code: LRO General Surgery Tray
Reason for recall: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: DeRoyal sent an urgent recall notice to its consignees on 12/12/2022 by email and they followed with a letter sent overnight to the end user. The notice explained the problem and the hazard, and requested the following actions be taken: "1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product. 2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory. Please return the completed form to DeRoyal via fax to 865-362-3716 or [email protected] no later than January 15, 2023. 3) If you have questions regarding credit for the recall, please contact Jennifer Marsh at [email protected] or by phone 865-362-4203 or email us at [email protected]. 4) PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5) If you have further distributed these products, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer listing and we will contact them."
Quantity in commerce: 157 packs
Distribution: US Nationwide distribution in the states of IL, MO.
Product codes and lots: a) REF 89-9004.09, GTIN 00749756903936, Lot Numbers: 57391129 exp 5/1/2023, 57755421 exp 5/1/2023, 57900931 exp 5/1/2023 b) REF 89-9004.10, GTIN 00749756903931, Lot Numbers: 57913767 exp 5/1/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0927-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0927-2023	Class II	Terminated	Voluntary: Firm initiated	2023-01-18	2023-01-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)