Z-1692-2023Class II

Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical...

Name: Z-1692-2023 Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical...
Creator: DeRoyal Industries Inc
Published: 2023-04-17
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2023-04-17 / Open, Classified / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK... on 2023-04-17. FDA classified it as Class II and gives the reason as "The custom procedure packs contain light handle covers that have been recalled by another firm". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1692-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-17
Posted: 2023-06-07
Recalling firm: DeRoyal Industries, Inc.
Product: Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
Product code: OHM Cesarean Section Tray
Reason for recall: The custom procedure packs contain light handle covers that have been recalled by another firm.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued a letter dated 4/14/2023 to their sole consignee via email on 4/17/2023. The letter explained the reason for recall, the risk associated with the use of the device, and referred the customer to see the attached Affected Products Listing for detailed information, as the spreadsheet indicates the DeRoyal product numbers and lot numbers shipped to the customer. Additionally, the spreadsheet indicates the STERIS reference number, LB53, and lot numbers affected. The letter points out the recall is for the sterile STERIS light handle cover and the rest of the pack is not affected or impacted by the recall. The customer is to take the following actions: (1) Using the attached Affected Products Listing, identify the affected surgical pack numbers in your inventory and place it in quarantine to prevent further use. Place the label provided on each case and individual pack indicating that upon use, to remove and discard/destroy the STERIS Light Handle Covers that are contained within the pack; (2) Complete the Notice of Destruction Form indicating the number of affected products labeled and the customer will be given credit for the product discarded/destroyed. The completed form was to be returned to the recalling firm via FAX or email no later than 5/12/2023. (3) The customer is to complete and return the notice of destruction form even if they no longer have any product. (4) If the product has been further distributed, they are to notify their customers of the recall, which can be done by forwarding the recall notification onto the downstream customer or having the recalling firm notify their downstream customers. The recalling firm later discovered there were additional products to be included in the recall and notified their sole consignee via email on 5/16/2023 containing an updated spreadsheet of products.
Quantity in commerce: 23 cases (52 packs)
Distribution: US Nationwide distribution in the state of VA.
Product codes and lots: (1) 89-10529.04 - lot 58700691, exp 11/1/2024, GTIN pack-00749756363334, case-50749756363339; (2) 89-10567.05 - lot 58700026, exp 12/1/2024, GTIN pack-00749756364300, case-50749756364305.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1692-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1691-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-07
Z-1692-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-14	2023-06-07

Product code OHM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)