FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
- Recall number
- Z-1668-2022
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
- Status
- Terminated
- Initiated
- 2022-08-12
- Posted
- not on file
- Terminated
- 2024-09-20
- Reason
- Procedure packs contained a recalled product.
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 1306 kits
- Distribution
- US Nationwide distribution in the states of OH and TN.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K842648
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28