DeRoyal Sterile Custom Kits Recalled for Unknown Contamination
DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown bioburden and particulate contamination.
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: The recall involves a risk-of-harm product (sterile medical device) with unknown contamination levels, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria for theoretical risk.
Plain-English summary
DeRoyal Industries, Inc. is recalling 2,100 units of DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. The recall involves specific catalog and lot numbers, including Catalog number 9541NA and Outpatient Major 89-3865.12.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. These conditions compromise the sterility of the medical devices.
The affected products were distributed to the U.S. Department of Veterans Affairs Medical Center in East Orange, New Jersey, and to Rhode Island. Consumers and healthcare facilities should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
- 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 (8)
- Catalog number 9541NA
- lot numbers 2708DJ1
- 3008DJ1
- 3008DSJ1 and 4418GSJ
- Outpatient Major 89-3865.12
- Lot numbers: 47061206 exp. 06/01/2022
- 49505579 exp. 03/01/2023
- 4955103 exp. 03/01/2023
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
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