Surgical Convenience Kits Recalled for Separating Light Handle Covers
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in 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: FDA Class II recall involving surgical equipment with a risk-of-harm hazard (light handle cover separation during use). The source text does not report any illnesses or injuries, making the hazard theoretical rather than realized, which per the rubric limits the score to at most 3.
Plain-English summary
ROi CPS LLC is recalling sterile surgical convenience kits (Item Numbers 880405003 for General Laparoscopy and 880424004 for Thoracic) due to a component defect. The kits contain light handle covers that may separate and fall off during surgical use.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle during use. A total of 278 kits were affected, distributed nationwide in Florida and Missouri. Two lots are involved: Lot #95475 (expiration 10/29/2024) and Lot #95493 (expiration 9/7/2024).
Patients and healthcare providers who have received or used these kits should stop use immediately and contact ROi CPS LLC with any questions or concerns.
The recalled product
- Product
- Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
- Manufacturer
- ROi CPS LLC
- Hazard
- component-separation
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 (5)
- 1. Lot #95475
- exp. 10/29/2024
- UDI (01)10194717112211(17)241029(10)95475. 2. Lot #95493
- exp. 9/7/2024
- UDI (01)10194717112327(17)240907(10)95493.
Distribution
Distributed nationwide across the United States.
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