Agency classClass IIOur severity:High FDA (Devices)·Z-1435-2023·Announced 2023-05-03

Sterile Surgical Kit Light Handle Covers May Separate During Use

ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a risk-of-harm product (surgical kit with component separation hazard) where no illnesses or injuries have been reported. Per the rubric, this places the recall at a maximum score of 3 (High).

Plain-English summary

ROi CPS LLC is recalling the WPH GYN Laparoscopy Pack, a sterile surgical convenience kit. The recall affects 386 kits identified by item number 800753005, GY00958E, lot #95517, with an expiration date of October 17, 2024.

The light handle covers that are part of this surgical kit may separate from the light handle and fall off during use. The manufacturer was notified of this issue by their supplier.

The affected kits were distributed nationwide to medical facilities in Florida and Missouri. No illnesses or injuries related to this issue have been reported.

The recalled product

Product: Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Manufacturer: ROi CPS LLC
Category: Medical Device — Surgical Equipment
Hazard: component-separation
Affected units: 386

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 #95517
exp. 10/17/2024
UDI (01)10194717108719(17)241017(10)95517.

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 →

Same manufacturer · ROi CPS LLC

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Same hazard · component separation