The Recall Desk
HighFDA (Devices)·Z-1692-2023·Announced 2023-06-14

Surgical Procedure Packs Recalled Due to Included Light Handle Covers

DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Classified as High severity because surgical procedure packs are risk-of-harm medical devices, and these contain a component that was previously recalled by another manufacturer. However, no illnesses or injuries have been reported, and the specific nature of the component defect is not disclosed in this notice.

Plain-English summary

DeRoyal Industries Inc is recalling custom sterile surgical procedure packs because they contain light handle covers that were previously recalled by another firm. The affected product models are 89-10529.04 (CNRV OR C-SECTION PACK for New River Valley Medical Center) and 89-10567.05 (OB-OR C-SECTION PACK for Carilion Roanoke Memorial Hospital).

Twenty-three cases containing a total of 52 packs were distributed in Virginia. The affected lots are 58700691 (model 89-10529.04, expiration 11/1/2024) and 58700026 (model 89-10567.05, expiration 12/1/2024). This is an FDA Class II recall.

The recalled product

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.
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Supplies
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • (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.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · DeRoyal Industries Inc

See all →