DeRoyal Sterile Custom Kits Recalled Due to Unknown Contamination Levels
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 Class II medical device with unknown contamination levels (bioburden, flora, particulates) representing a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
DeRoyal Industries, Inc. is recalling DeRoyal Sterile Custom Kits containing Cardinal Health gowns. The recall affects 2,100 units of the ASC Thyroid Pack 89-6302.14. The products were distributed in Rhode Island and New Jersey, specifically to the V.A. Med Ctr East Orange.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The agency has classified this as a Class II recall.
Affected products include Catalog number 9541NA with lot numbers 2708DJ1, 3008DJ1, 3008DSJ1, and 4418GSJ. Additionally, ASC Thyroid Pack 89-6302.14 with lot numbers 49310958 (exp. 09/01/2023) and 49675501 (exp. 09/01/203) are included. 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: ASC Thyroid Pack 89-6302.14
- Manufacturer
- Deroyal Industries, Inc. Lafollette
- Category
- Medical Device — Surgical Kits
- 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 (7)
- Catalog number 9541NA
- lot numbers 2708DJ1
- 3008DJ1
- 3008DSJ1 and 4418GSJ
- ASC Thyroid Pack 89-6302.14
- Lot numbers: 49310958 exp. 09/01/2023
- 49675501 exp. 09/01/203
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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