FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: 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.
- Recall number
- Z-1692-2023
- 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.
- Status
- Open, Classified
- Initiated
- 2023-04-17
- Posted
- 2023-06-07
- Terminated
- not on file
- Reason
- The custom procedure packs contain light handle covers that have been recalled by another firm.
- 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
- 23 cases (52 packs)
- Distribution
- US Nationwide distribution in the state of VA.
- Lot, serial or model codes
- (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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHM
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28