DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden 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. The hazard involves unknown contamination levels in sterile medical devices, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
DeRoyal Industries, Inc. is recalling DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. The specific product affected is the Cystoscopy Pack 89-6071.15. The recall involves 2,100 units.
The recall was initiated because the Cardinal Health gowns contained in these kits have an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. This contamination status presents a potential risk to patient safety during sterile procedures.
The affected products were distributed in Rhode Island and New Jersey, specifically to the V.A Med Ctr East Orange. The recall includes items with Catalog number 9541NA and lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, and 4418GSJ. The Cystoscopy Pack 89-6071.15 is identified by Lot number 49442168 with an expiration date of 03/01/2021. Users should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
- Manufacturer
- Deroyal Industries, Inc. Lafollette
- 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
- Cystoscopy Pack 89-6071.15
- Lot number: 49442168 exp 03/01/2021
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.
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