Agency classClass IIOur severity:High FDA (Devices)·Z-1691-2023·Announced 2023-06-14

Sterile Surgical Procedure Packs Recalled for Defective Light Handle Covers

DeRoyal Industries is recalling 2,972 sterile surgical procedure packs containing light handle covers that have been recalled by another manufacturer. The affected packs were distributed to hospitals in Virginia.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This FDA Class II recall involves sterile surgical procedure packs used in medical facilities. The rubric specifies that risk-of-harm products where injury has not yet been reported should score 3. No illnesses or injuries are reported in the source material.

Plain-English summary

DeRoyal Industries Inc is recalling 1,391 cases (2,972 packs) of sterile custom surgical procedure packs. The recalled products include 26 different surgical procedure pack configurations for various surgical specialties, including total knee, laparotomy, laparoscopy, spine, cardiac, and other surgical procedures.

The surgical packs contain light handle covers that have been recalled by another firm. This is an FDA Class II medical device recall, indicating potential health risk.

The affected packs were distributed in Virginia to multiple hospitals, including Stonewall Jackson Hospital, New River Valley Medical Center, and Carilion Roanoke Memorial Hospital.

The recalled product

Product: Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River…
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Surgical Procedure Packs
Hazard: component-defect

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 (20)

(1) 89-10507.02 - lot 58700464
exp 12/1/2024
GTIN pack-00749756362788
case-50749756362783
(2) 89-10508.02 - lot 58700430
exp 9/1/2026
GTIN pack-00749756362818
case-50749756362813
(3) 89-10509.02 - lot 58775010
GTIN pack-00749756362832
case-50749756362837
(4) 89-10517.04 - lot 58700579
GTIN pack-00749756363228
case-50749756363223
(5) 89-10526.04 - lot 58388765
exp 11/1/2024
GTIN pack-00749756363242
case-50749756363247
(6) 89-10530.04 - lot 58543121
GTIN pack-00749756364447

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 →

Same manufacturer · DeRoyal Industries Inc

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Same hazard · component defect