Z-0637-2018Class II

Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO...

Name: Z-0637-2018 Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO...
Creator: DeRoyal Industries Inc
Published: 2018-01-22
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2018-01-22 / Terminated / root cause: sterility

FDA source

DeRoyal Industries Inc began a recall of Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy on 2018-01-22. FDA classified it as Class II and gives the reason as "DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0637-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-22
Posted: 2018-02-16
Terminated: 2020-08-19
Recalling firm: DeRoyal Industries, Inc.
Product: Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
Product code: LRO General Surgery Tray
Reason for recall: DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
Root cause tag: sterility
FDA root cause: Process change control
Action: The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 01/22/18 to its Consignees on 1/22/18 by overnight mail. The firm sent a follow-up "URGENT! RECALL NOTICE" letter dated 1/29/18. The letters described the product, problem and actions to be taken. The Consignees were instructed to identify affected products; place in quarantine; complete and return the Notice of Return Form, even if they no longer held any affected product, to DeRoyal via fax to 865-362-3716 or email to [email protected] no later than 3/1/18, and return any product they held in stock. If you have further distributed these products, notify your customers of this recall. If you have questions or need assistance with the recall, please contact Regulatory Recall Coordinator and Quality Projects Manager at [email protected] or by phone 865-362-4203 or email us at [email protected].
Quantity in commerce: 181 units
Distribution: US Distribution to: NY
Product codes and lots: Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0637-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0637-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-16

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