The Recall Desk
HighFDA (Devices)·Z-1437-2023·Announced 2023-05-03

Surgical Convenience Kits Recalled Due to 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 affected kits were 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: This is an FDA Class II recall with no reported injuries or hospitalizations. The hazard involves a surgical device component that may separate during use, creating a risk of harm in a safety-critical context, but no actual incidents have been reported.

Plain-English summary

ROi CPS LLC is recalling five models of sterile surgical convenience kits due to a defect in the light handle covers. The covers may separate from the light handle and fall off during use, potentially creating a safety hazard in the surgical environment.

The recall involves five kit models: OH Laminectomy (Item #800756005, NU00961E), Lumbar Universal (Item #880411008, NU01018H), Craniotomy (Item #880396007, NU01001G), Anterior/Cervical Spine (Item #880387005, NU00991E), and ORMC Major Crani Pack (Item #800716005, NU00921E). A total of 456 kits were distributed nationwide in Florida and Missouri. Six lot numbers are affected, with expiration dates ranging from May 2024 to November 2024.

If you have received any of these kits, contact ROi CPS LLC immediately for instructions on return, replacement, or destruction of the affected products. Do not use the kits until you have received guidance from the manufacturer. For additional information, contact the FDA or visit the FDA's recall page for this product (Z-1437-2023).

The recalled product

Product
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - An
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Kits
Hazard
  • component-separation
  • surgical-device-defect

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 (17)

  • 1. Lot #95370
  • exp. 10/29/2024
  • UDI (01)10194717111023(17)241029(10)95370
  • 2. Lot #95477
  • exp. 6/30/2024
  • UDI (01)10194717112242(17)240630(10)95477
  • 3. Lot #95506
  • exp. 5/31/2024
  • UDI (01)10194717114130(17)240531(10)95506
  • 4. Lot #95632
  • exp. 5/30/2024
  • UDI (01)10194717112709(17)240530(10)95632
  • and 5. Lot #95646
  • exp. 11/15/2024
  • UDI (01)10194717110880(17)241115(10)95646
  • and Lot #95309
  • UDI (01)10194717110880(17)241029(10)95309.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category