Z-1051-2022Class II

Regard brand CABG Pack A and B - Spartanburg

Name: Z-1051-2022 Regard brand CABG Pack A and B - Spartanburg
Creator: ROi CPS LLC
Published: 2022-03-21
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2022-03-21 / Terminated

FDA source

ROi CPS LLC began a recall of Regard brand CABG Pack A and B - Spartanburg on 2022-03-21. FDA classified it as Class II and gives the reason as "Kits were packed into shipping boxes incorrectly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1051-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-21
Posted: 2022-05-09
Terminated: 2023-12-28
Recalling firm: ROi CPS LLC
Product: Regard brand CABG Pack A and B - Spartanburg
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Kits were packed into shipping boxes incorrectly.
FDA root cause: Under Investigation by firm
Action: An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to [email protected] so a return can be arranged. 4) Notify: Notify immediately any customers to whom you have distributed or forwarded product affected by this recall. Include the recall letter to supplement your notification.
Quantity in commerce: 85 kits
Distribution: Recall impacted one domestic consignee in NC
Product codes and lots: Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1051-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1051-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-18	2022-05-09

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)