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Sterile custom surgical procedure packs recallZ-1692-2023 · DeRoyal Industries Inc · initiated Apr 17, 2023

Class II Open, Classified All recalls posted in June 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The custom procedure packs contain light handle covers that have been recalled by another firm.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1692-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 17, 2023
Posted by the FDA
Jun 7, 2023
Recalling firm
DeRoyal Industries Inc
Quantity
23 cases (52 packs)
Product code
OHM
Distribution
US Nationwide distribution in the state of VA.

Product description

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.

Code information (models, lots, serial numbers)

(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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92299).

Sources and updates

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