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 is classified as FDA Class II, and the hazard involves unknown contamination in sterile medical devices, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
DeRoyal Industries, Inc. is recalling DeRoyal Sterile Custom Kits containing Cardinal Health gowns. The recall involves 2,100 units of the product, specifically the Shoulder Pack 89-4751.08. The affected lots include catalog number 9541NA with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, and 4418GSJ, as well as Shoulder Pack 89-4751.08 with lot number 49505405 and an expiration date of 11/01/2021.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. These defects compromise the sterility of the medical devices.
The affected 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 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: Shoulder Pack 89-4751.08
- 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
- Shoulder Pack 89-4751.08
- Lot number: 49505405 exp. 11/01/2021
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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