DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
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: The recall involves a risk-of-harm product (sterile medical device) with contamination hazards where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
DeRoyal Industries, Inc. is recalling DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. The specific product affected is the Kwik Kit 89-6389.06. The recall involves 2,100 units.
The recall is being issued because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The affected lots include catalog number 9541NA with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, and 4418GSJ, as well as Kwik Kit 89-6389.06 with lot number 49624025 and an expiration date of 07/01/2023.
The products were distributed in Rhode Island and New Jersey, specifically to the V.A Med Ctr East Orange. Consumers and healthcare facilities should stop using the affected products and contact DeRoyal Industries for further instructions.
The recalled product
- Product
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
- Manufacturer
- Deroyal Industries, Inc. Lafollette
- Category
- Medical Device — Surgical Gowns
- Affected units
- 2,100
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 (6)
- Catalog number 9541NA
- lot numbers 2708DJ1
- 3008DJ1
- 3008DSJ1 and 4418GSJ
- Kwik Kit 89-6389.06
- Lot number: 49624025 exp. 07/01/2023
Distribution
Part of a larger recall action
This product is one of 10 recalled by Deroyal Industries, Inc. Lafollette 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 10 products in this recall →Related recalls
Same manufacturer · Deroyal Industries, Inc. Lafollette
See all →- SevereDeRoyal Procedure Packs with NORMOFLO Warming Sets Recalled for Aluminum Leaching
FDA (Devices) · 2021-10-06
- ModerateTeleflex Pilling Aortic Punch Recalled for Potential Sterile Packaging Compromise
FDA (Devices) · 2020-03-25
- HighDeRoyal Sterile Custom Kits Recalled Due to Unknown Contamination Levels
FDA (Devices) · 2020-03-11
- HighDeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
FDA (Devices) · 2020-03-11
- HighDeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
FDA (Devices) · 2020-03-11
Same hazard · contamination
See all →- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02