Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

FDA device recall Z-0315-2024 · posted 2023-11-16 · Open, Classified

Recall details

Recalling firm

ROi CPS LLC

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.

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.

Root cause

Other

Status

Open, Classified

Product code

OEZ

Quantity affected

134 units

Distribution

MO

Date initiated

2023-09-21

Date posted

2023-11-16

Location

Republic, MO