Z-1668-2022 Class II Terminated
FDA device recall Z-1668-2022 was initiated by DeRoyal Industries Inc on Aug 12, 2022 and is designated Class II. Reason for recall: Procedure packs contained a recalled product. The recall status is terminated (terminated Sep 20, 2024). Affected quantity: 1306 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 7, 2022
- Initiation Date
- Aug 12, 2022
- Termination Date
- Sep 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1306 kits
Product Description
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Reason for Recall
Procedure packs contained a recalled product.
Distribution Pattern
US Nationwide distribution in the states of OH and TN.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1668-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026