Regard™
Open Heart Basin PK Part C
1manufacturer
192catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | ROi CPS LLC |
|---|---|
| FDA product code | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Premarket notification | Exempt |
| Record published | 2024-03-08 |
| Record revised | 2025-04-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 2, pack of 3, pack of 4, pack of 10, pack of 8 |
| Distribution end date | 2026-01-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CV01251 | Withdrawn | |
| CV01003G | Withdrawn | |
| CV00247J | Withdrawn | |
| CV01005J | Withdrawn | |
| CV00190S | Withdrawn | |
| CV01060 | Withdrawn | |
| CV01171A | Withdrawn | |
| CV00956C | Withdrawn | |
| CV00190R | Withdrawn | |
| CV00932D | Withdrawn | |
| CV00965B | Withdrawn | |
| HT00144M | Withdrawn | |
| CV00440N | Withdrawn | |
| CV01059 | Withdrawn | |
| CV00283K | Withdrawn | |
| CV00256M | Withdrawn | |
| CV00820I | Withdrawn | |
| CV01003H | Withdrawn | |
| CV01172A | Withdrawn | |
| CV00368I | Withdrawn | |
| CV00080AA | Withdrawn | |
| CV00368G | Withdrawn | |
| CV01172C | Withdrawn | |
| CV00214N | Withdrawn | |
| CV01172E | Withdrawn | |
| SP01145A | Withdrawn | |
| CV01251A | Withdrawn | |
| CV00932K | Withdrawn | |
| HT01125 | Withdrawn | |
| CV00913A | Withdrawn | |
| CV00214Q | Withdrawn | |
| CV00188S | Withdrawn | |
| CV00965A | Withdrawn | |
| CV00966B | Withdrawn | |
| CV00214T | Withdrawn | |
| CV00820L | Withdrawn | |
| CV01003N | Withdrawn | |
| CV00440Q | Withdrawn | |
| CV00820J | Withdrawn | |
| CV00213M | Withdrawn | |
| CV00261M | Withdrawn | |
| CV00283L | Withdrawn | |
| HT01069 | Withdrawn | |
| CV01003M | Withdrawn | |
| CV00188U | Withdrawn | |
| CV01003K | Withdrawn | |
| CV00820H | Withdrawn | |
| CV00357G | Withdrawn | |
| CV00054L | Withdrawn | |
| CV00820K | Withdrawn | |
| HT00161N | Withdrawn | |
| CV00852E | Withdrawn | |
| OR00994F | Withdrawn | |
| CV00213L | Withdrawn | |
| CV00956A | Withdrawn | |
| CV00337H | Withdrawn | |
| HT00144O | Withdrawn | |
| CV00956F | Withdrawn | |
| OR00994C | Withdrawn | |
| CV01003O | Withdrawn | |
| CV00357E | Withdrawn | |
| CV01061 | Withdrawn | |
| CV00852G | Withdrawn | |
| CV01171D | Withdrawn | |
| CV01171 | Withdrawn | |
| CV01003L | Withdrawn | |
| CV00361O | Withdrawn | |
| CV01038G | Withdrawn | |
| CV00932G | Withdrawn | |
| CV00852I | Withdrawn | |
| CV01005I | Withdrawn | |
| HT01069B | Withdrawn | |
| CV00256LM | Withdrawn | |
| HT01069A | Withdrawn | |
| CV00033L | Withdrawn | |
| CV00283O | Withdrawn | |
| CV00190Q | Withdrawn | |
| CV00213K | Withdrawn | |
| CV00979A | Withdrawn | |
| CV00361P | Withdrawn | |
| CV01003I | Withdrawn | |
| CV00188V | Withdrawn | |
| CV00332O | Withdrawn | |
| CV00368H | Withdrawn | |
| CV00335I | Withdrawn | |
| CV00361R | Withdrawn | |
| CV00361N | Withdrawn | |
| CV01171C | Withdrawn | |
| OR00379F | Withdrawn | |
| CV00256J | Withdrawn | |
| CV01005H | Withdrawn | |
| CV00361Q | Withdrawn | |
| CV01171E | Withdrawn | |
| CV00440P | Withdrawn | |
| CV00357D | Withdrawn | |
| HT00161M | Withdrawn | |
| CV00080Y | Withdrawn | |
| HT00330N | Withdrawn | |
| CV00054M | Withdrawn | |
| CV00188P | Withdrawn | |
| CV00932F | Withdrawn | |
| CV00079K | Withdrawn | |
| CV00361R | Withdrawn | |
| CV00214S | Withdrawn | |
| CV00261K | Withdrawn | |
| CV00256N | Withdrawn | |
| CV00054O | Withdrawn | |
| CV00339Q | Withdrawn | |
| CV00188R | Withdrawn | |
| CV01172D | Withdrawn | |
| CV00852H | Withdrawn | |
| CV00256I | Withdrawn | |
| CV00820M | Withdrawn | |
| HT00144N | Withdrawn | |
| CV00245L | Withdrawn | |
| CV00188Q | Withdrawn | |
| CV01005G | Withdrawn | |
| CV00852D | Withdrawn | |
| SP01145B | Withdrawn | |
| CV01059B | Withdrawn | |
| CV00283N | Withdrawn | |
| CV01003J | Withdrawn | |
| CV00214P | Withdrawn | |
| CV00956E | Withdrawn | |
| SP01079A | Withdrawn | |
| CV01003Q | Withdrawn | |
| CV01062 | Withdrawn | |
| CV01003P | Withdrawn | |
| CV00932J | Withdrawn | |
| CV00357F | Withdrawn | |
| CV00189H | Withdrawn | |
| CV00929A | Withdrawn | |
| SP01145 | Withdrawn | |
| CV00852F | Withdrawn | |
| CV00213N | Withdrawn | |
| CV00189I | Withdrawn | |
| CV01038F | Withdrawn | |
| CV01038D | Withdrawn | |
| CV01172 | Withdrawn | |
| CV00214O | Withdrawn | |
| CV00966C | Withdrawn | |
| CV00188T | Withdrawn | |
| CV01003E | Withdrawn | |
| OR00994D | Withdrawn | |
| CV00080Z | Withdrawn | |
| CV00214R | Withdrawn | |
| CV00440M | Withdrawn | |
| CV00440O | Withdrawn | |
| CV00966A | Withdrawn | |
| HT01074A | Withdrawn | |
| CV00956D | Withdrawn | |
| HT01301A | Withdrawn | |
| CV01060A | Withdrawn | |
| CV00932H | Withdrawn | |
| CV01059A | Withdrawn | |
| CV00261J | Withdrawn | |
| CV00256J | Withdrawn | |
| CV00932E | Withdrawn | |
| HT01301 | Withdrawn | |
| CV00190P | Withdrawn | |
| CV00979B | Withdrawn | |
| OR00231J | Withdrawn | |
| CV00261L | Withdrawn | |
| CV00261I | Withdrawn | |
| CV00956B | Withdrawn | |
| CV00077O | Withdrawn | |
| CV00080X | Withdrawn | |
| CV00079J | Withdrawn | |
| CV00256L | Withdrawn | |
| OR00994E | Withdrawn | |
| CV00956G | Withdrawn | |
| CV01003F | Withdrawn | |
| CV00256K | Withdrawn | |
| CV00283M | Withdrawn | |
| CV00932B | Withdrawn | |
| CV00932C | Withdrawn | |
| CV00245K | Withdrawn | |
| CV00932I | Withdrawn | |
| SP01079 | Withdrawn | |
| HT00330O | Withdrawn | |
| CV00913B | Withdrawn | |
| CV01171B | Withdrawn | |
| HT01125A | Withdrawn | |
| CV01038E | Withdrawn | |
| CV00054N | Withdrawn | |
| CV01172B | Withdrawn | |
| CV01005F | Withdrawn | |
| OR00994B | Withdrawn | |
| CV00077P | Withdrawn | |
| CV00956H | Withdrawn | |
| CV01005E | Withdrawn | |
| CV00077N | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 40,731 |
| Medline Industries, Inc. | Medline Industries, Inc. | 17,468 |
| Avid TruCustom | Avid Medical, Inc. | 2,785 |
| Namic | Medline Industries, Inc. | 2,718 |
| Merit Medical® | Merit Medical Systems, Inc. | 2,399 |
| Halyard | Avid Medical, Inc. | 2,108 |
| ACS | American Contract Systems, Inc. | 1,540 |
| Medline | Medline Industries, Inc. | 428 |
| Stradis Healthcare | Stradis Healthcare | 263 |
| Stradis | Stradis Healthcare | 108 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 72 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 51 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ROi CPS LLC | UDI-DI | 2024-06-17 | Class II | Pending | Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. | 78 Kits | |
| ROi CPS LLC | UDI-DI | 2023-09-21 | Class II | Other | 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 | 134 units | |
| ROi CPS LLC | UDI-DI | 2022-10-20 | Class II | Component change control | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 108 kits | 2026-04-01 |
| ROi CPS LLC | UDI-DI | 2022-06-03 | Class II | Process change control | Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. | 86 kits | 2023-04-14 |
| ROi CPS LLC | UDI-DI | 2022-05-20 | Class II | Process change control | A nonsterile component was packaged in a sterile convenience kit. | 180 kits | 2023-05-02 |
| ROi CPS LLC | UDI-DI | 2022-03-21 | Class II | Under Investigation by firm | Kits were packed into shipping boxes incorrectly. | 85 kits | 2023-12-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2021-03-04 | Class II | Process control | 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 b | 16 kits |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.