The Recall Desk
HighFDA (Devices)·Z-0290-2023·Announced 2022-11-30

Eye Surgery Convenience Kits Recalled for Containing Recalled 3M Drapes

ROi CPS LLC recalled 76 regard Vitrectomy Pack surgical kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contained 3M surgical drapes that were subsequently recalled.

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 of surgical devices, which are risk-of-harm products by nature. No illnesses or injuries have been reported in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score as 3 (High).

Plain-English summary

ROi CPS LLC is recalling 76 regard VITRECTOMY PACK surgical kits (Model EY00266H, Item Number 800028008). These surgical convenience kits, classified as Class II by the FDA, were distributed in Louisiana, Missouri, North Carolina, and Florida. The kits are being recalled because they contain 3M surgical drapes which were subsequently recalled.

The affected lot is Lot Number 92222 with an expiration date of April 2024. The Universal Device Identifier (UDI) is 10194717107897.

The recalled product

Product
regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
Manufacturer
ROi CPS LLC
Hazard
  • 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 (3)

  • UDI/DI 10194717107897
  • Lot Numbers: 92222
  • exp 4/21/2024

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC