Z-1140-2021Class II

Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure...

Name: Z-1140-2021 Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure...
Creator: DeRoyal Industries Inc
Published: 2021-01-25
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2021-01-25 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades on 2021-01-25. FDA classified it as Class II and gives the reason as "Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker". 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-1140-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-25
Posted: 2021-02-19
Terminated: 2022-07-21
Recalling firm: DeRoyal Industries, Inc.
Product: Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
Product code: LRO General Surgery Tray
Reason for recall: Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DeRoyal issued their recall on 01/25/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal.
Quantity in commerce: 776 packs
Distribution: Distributors in OK, MI, and TX.
Product codes and lots: a) 89-9194.07, Lot Numbers; 47782581 exp 5/1/2021 b) 89-9194.09, Lot Numbers: 50224694 exp 9/1/2023, 50326092 exp 9/1/2023, 50582301 exp 9/1/2023, 50795307 exp 11/1/2023, 51008862 exp 11/1/2023, 51153103 exp 11/1/2023 c) 89-9194-10, Lot Numbers: 51434221 exp 11/1/2023, 51881522 exp 11/1/2023 d) 89-9194-11, Lot Numbers: 52175785 exp 8/1/2022, 52849153 exp 11/1/2023, 53220664 exp 2/1/2025, 53327306 exp 2/1/2025, 53409521 exp 9/1/2023, 53565355 exp 12/1/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1138-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-19
Z-1139-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-19
Z-1140-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-19

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)