The Recall Desk
HighFDA (Devices)·Z-1434-2023·Announced 2023-05-03

Sterile surgical cardiac catheterization kit recalled for light handle cover separation

A sterile surgical convenience kit for cardiac catheterization is being recalled because light handle covers may separate and fall off during use. The affected lot includes 322 kits distributed to Florida and Missouri.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard involves mechanical failure of a surgical kit component during cardiac catheterization, creating a risk-of-harm scenario. Per the rubric, Class II recalls without reported injuries but with genuine risk of harm are rated as High (3).

Plain-English summary

ROi CPS LLC is recalling 322 units of a sterile surgical convenience kit for cardiac catheterization procedures. The kit is identified as Item Number 880393003, HT00997C, Lot #95383, with an expiration date of 10/29/2024. The light handle covers, a component of the kit, may separate from the light handle and fall off during use.

The recall was initiated after ROi CPS LLC's supplier notified the firm that this separation can occur. The affected kits were distributed nationwide in the United States, including Florida and Missouri.

The recalled product

Product
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Manufacturer
ROi CPS LLC
Category
Medical Device — Cardiac catheterization kit
Hazard
Affected units
322

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #95383
  • exp. 10/29/2024
  • UDI (01)10194717105374(17)241029(10)95383.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 8 recalled by ROi CPS LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · ROi CPS LLC

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Same hazard · component separation

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