FDA Device recall Z-1376-2021
Regard, Item Number 830067009, custom cardiovascular procedure kit
- FDA Device
- Class II
- ongoing
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of Regard, Item Number 830067009, custom cardiovascular procedure kit by Roi Cps, citing ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1376-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-04 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Regard, Item Number 830067009, custom cardiovascular procedure kit
Reason
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
Identifiers
| code_info | Lot number: 75818I; Expiration Date: 05/18/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1376-2021%22
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