DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels
DeRoyal is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, 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 is classified as FDA Class II. The hazard involves unknown contamination in sterile medical devices, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
DeRoyal Industries, Inc. is recalling DeRoyal Sterile Custom Kits containing Cardinal Health gowns. The recall involves 2,100 units of the Ophthalmology CSTM PCK 89-6387.08 product. The specific lots affected are 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, and 49512592 (expiration date 07/01/2022).
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. These conditions compromise the sterile integrity 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 the affected kits and contact DeRoyal Industries for further instructions or a return.
The recalled product
- Product
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
- 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
- Opthalmology CSTM PCK 89-6387.08
- Lot number: 49512592 exp. 07/01/2022
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.
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