Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
- Company
- Roi Cps Llc
- Recall Initiated
- September 21, 2023
- Posted
- November 16, 2023
- Recall Number
- Z-0315-2024
- Quantity
- 134 units
- Firm Location
- Republic, MO
Reason for Recall
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Distribution
MO
Lot / Code Info
a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442
Root Cause
Other
Action Taken
ROi CPS, LLC issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 09/29/2023 via email. The email attached the notice and the notice received from Getinge. The notice explained the issue, the potential risks, and requested the distributor notify their customer. End user was directed to post the Getinge notice in area where the affect kits were used. An updated notice was sent on 10/13/2023 via email with the corrected item numbers with the same instructions.