Sterile surgical convenience kit: regard Item Number:… recallZ-1434-2023 · ROi CPS LLC · initiated Mar 22, 2023

Why it was recalled

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

FDA root cause category: Nonconforming Material/Component

What the company is doing

The recalling firm issued letters dated 3/22/2023 via email the same day. The letter explained the issue, identified the affected product, and listed the actions to be taken by the customer. The actions included checking their inventory for the affected product, segregate and quarantine all affected kits in their inventory, and use the attached label template to print warning labels to be affixed to all affected kits in their inventory. The label should be applied to each affected kit and outer product case in a prominent location to end users of the kits. The location chosen should not cover critical product information found on the existing label. The label instructs users to remove and discard the STERIS Light Handle Cover(s) when the kit is opened for use and to pull a sterile replacement from stock. A reply form is included with the letter for completion to indicate the consignee's actions in response to the notice. The response form is to be returned to the recalling firm via email. If the direct account consignee further distributed or forwarded the affected product, they are to immediately notify those customers. A copy of the ROi CPS recall letter, the letter from STERIS, and the attached label template may be included.

Recall details

Recall number

Z-1434-2023

Status

Open, Classified

Initiated by the company

Mar 22, 2023

Posted by the FDA

Apr 25, 2023

Recalling firm

ROi CPS LLC

Quantity

322 kits

Product code

OES

Distribution

US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

Product description

Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.

Devices named in this recall

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

• Regard™ HT00997C

  Roi Cps, LLC · Cardiac Catheterization Kit
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 91984).

• Z-1431-2023 · Open, Classified
  Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
• Z-1432-2023 · Open, Classified
  Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item …
• Z-1433-2023 · Open, Classified
  Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
• Z-1435-2023 · Open, Classified
  Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
• Z-1436-2023 · Open, Classified
  Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
• Z-1437-2023 · Open, Classified
  Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3.…
• Z-1438-2023 · Open, Classified
  Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item N…