Agency classClass IIOur severity:High FDA (Devices)·Z-2090-2023·Announced 2023-07-12

Custom Medical Procedure Packs Recalled for Compromised Package Seals

DeRoyal Industries is recalling 306 custom medical procedure packs because the outer package seals could be open or compromised, affecting the sterility of the contents. Affected packs were distributed nationwide.

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 is an FDA Class II recall with no reported illnesses or injuries. The hazard presents a risk of infection if compromised packs are used in sterile medical procedures, meeting the criterion for High severity as a risk-of-harm product without reported injury.

Plain-English summary

DeRoyal Industries Inc. is recalling three types of custom medical procedure packs due to potentially compromised outer package seals. The affected products are the CATH ANGIOGRAPHY DRAPE PACK (REF 89-7102), CHOLANGIOGRAPHY KIT (REF 89-7322), and CATH LAB PACK (REF 89-9183).

The outer package seal could be open or compromised, which affects the sterility of the procedure pack inside. If a seal is compromised, the contents may be exposed to contamination, creating a potential infection risk when used in medical procedures.

A total of 306 packs were distributed nationwide. The affected lot numbers are 58806701 (REF 89-7102), 58821231 (REF 89-7322), and 58741944 (REF 89-9183).

Healthcare facilities and users in possession of these packs should discontinue use and contact DeRoyal Industries with the lot number and reference number for further instructions.

The recalled product

Product: Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Surgical Procedure Packs
Hazard: sterility-breach
infection-risk
Affected units: 306

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 (12)

a) REF 89-7102
GTIN 50749756734085 (cs)
00749756734080 (unit)
Lot Numbers: 58806701
b) REF 89-7322
GTIN 50749756736171 (cs)
00749756736176 (unit)
Lot Numbers: 58821231
c) REF 89-9183
GTIN '0749756904846 (cs)
00749756904841 (unit)
Lot Numbers: 58741944

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · DeRoyal Industries Inc

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Same hazard · sterility breach