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regard BASIC NEURO, NU00259S, Item Number 800021019 recallZ-0288-2023 · ROi CPS LLC · initiated Oct 20, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

FDA root cause category: Component change control

What the company is doing

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"

Recall details

Recall number
Z-0288-2023
Status
Terminated
Initiated by the company
Oct 20, 2022
Posted by the FDA
Nov 23, 2022
Recalling firm
ROi CPS LLC
Quantity
160 units
Product code
OJG
Distribution
LA, MO, NC, FL

Product description

regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit

Code information (models, lots, serial numbers)

UDI/DI 10194717115397, Lot Numbers: 92346, exp 2/14/2024

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91069).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page