DeRoyal Sterile Custom Kits Recalled for Defective Connectors
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors are being recalled because the procedure packs contained a recalled product. Approximately 1,306 kits were distributed in Ohio and Tennessee.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The specific defect associated with the recalled connector components is not detailed in the recall notice.
Plain-English summary
DeRoyal Industries Inc has recalled DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors. The kits were distributed nationwide in Ohio and Tennessee, with approximately 1,306 units affected.
The procedure packs were recalled because they contained a recalled product. The specific nature of the defect with the MicroClave Clear Connectors is not detailed in the recall notice.
Healthcare facilities or consumers with these kits should discontinue use of the affected lots. For replacement or further instructions, contact DeRoyal Industries Inc. The affected lots include NS CVR PREP PACK (code 89-6817.09) in lots 56391514, 56926777, and 57103035 (all expiring 08/01/2023), and NON-STERILE IR ADMISSION KIT (code 89-8762.05) in lot 57104020 (expiring 07/01/2023).
The recalled product
- Product
- DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 1,306
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)
- NS CVR PREP PACK /89-6817.09
- Lots 56391514 (exp 08/01/2023)
- 56926777 (exp 08/01/2023)
- 57103035 (exp. 08/01/2023)
- UDI-DI (GTIN): 00749756730938 NON-STERILE IR ADMISSION KIT / 89-8762.05
- Lot 57104020 (exp 07/01/2023)
- UDI-DI (GTIN): 00749756883627
Distribution
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