| Class 2 Device Recall Regard |  |
Date Initiated by Firm | September 21, 2023 |
Date Posted | November 16, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0315-2024 |
Recall Event ID |
93204 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
Product | Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit |
Code Information |
a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436;
b) UDI/DI 10194717117049, Lot Numbers: 96442
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Recalling Firm/ Manufacturer |
ROi CPS LLC 3000 E Sawyer Rd Republic MO 65738-2758
|
For Additional Information Contact | 417-730-3900 |
Manufacturer 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. |
FDA Determined Cause 2 | Other |
Action | 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. |
Quantity in Commerce | 134 units |
Distribution | MO |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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