Recalls / —
—#195629
Product
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
- FDA product code
- LRO — General Surgery Tray
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K842648
- Affected lot / code info
- 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
Why it was recalled
Procedure packs contained a recalled product.
Root cause (FDA determination)
Material/Component Contamination
Action the firm took
DeRoyal issued their recall notification on 08/12/2022 to the end user level by emailing recall letters to affected consignees. The consignees are asked to identify the affected products and return any affected product and to complete the return form back to DeRoyal.
Recalling firm
- Firm
- DeRoyal Industries Inc
- Address
- 200 Debusk Ln, Powell, Tennessee 37849-4703
Distribution
- Distribution pattern
- US Nationwide distribution in the states of OH and TN.
Timeline
- Recall initiated
- 2022-08-12
- Terminated
- 2024-09-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #195629. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.