Z-0313-2023Class II

regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit

Name: Z-0313-2023 regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
Creator: ROi CPS LLC
Published: 2022-10-20
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2022-10-20 / Terminated

FDA source

ROi CPS LLC began a recall of regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit on 2022-10-20. FDA classified it as Class II and gives the reason as "Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0313-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-20
Posted: 2022-11-23
Terminated: 2026-04-01
Recalling firm: ROi CPS LLC
Product: regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
Product code: OJG Neurological Tray
Reason for recall: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
FDA root cause: Component change control
Action: ROi CPS, LLC issued a MEDICAL DEVICE CORRECTION NOTICE on 10/20/2022 by email to its consignees. The notice explained the issue, the distribution dates, and kits specific to each consignee, and requested the following: "Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the chart above are in your inventory. 2. QUARANTINE: Segregate and quarantine all affected kits in your inventory. 3. LABEL: Use the attached label template (Ro; CPS Correction INC13225-3M Recall Label Template-Avery 5960) to print warning labels to be affixed to all affected kits in your inventory. The label should be applied to each affected Kit and outer product case in a prominently visible location to end-users of the kits. The location chosen should not cover any other critical product information found on the existing product labeling. The label instructs users to remove and discard the 3M Steri-Drapes when the kit is opened for use. 4. REPLY: Complete the reply form included with this notice to indicate your actions in response to this notice. a. If you do not have inventory, please return the form indicating "0" affected inventory at your facility. b. Return the reply form to [email protected] 5. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this notice, the notice from 3M, and the attached label template with your customer notification. 6. REPORT: Report any adverse health consequences experienced with the 3M products to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852-9787"
Quantity in commerce: 188 kits
Distribution: LA, MO, NC, FL
Product codes and lots: UDI/DI 10194717109457, Lot Numbers: 92239, exp 11/27/2023; 91440, exp 12/7/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0313-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0283-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0284-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0285-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0286-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0287-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0288-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0289-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0290-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0291-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0292-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0293-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0294-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0295-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0296-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0297-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0298-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0299-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0300-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0301-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0302-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0303-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0304-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0305-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0306-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0307-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0308-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0309-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0310-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0311-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0312-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0313-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0314-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0315-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0316-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0317-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0318-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0319-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0320-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0321-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23
Z-0322-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-23

Product code OJG

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)