The Recall Desk
HighFDA (Devices)·Z-0291-2023·Announced 2022-11-30

Surgical convenience kits recalled due to included recalled 3M drapes

Surgical convenience kits (regard NEURO PACK) were recalled because they contain 3M surgical drapes that are subject to a separate recall. Affected units were distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida.

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 a medical device. No illnesses or injuries are reported in the recall notice. The product is a surgical convenience kit containing recalled surgical drapes, presenting a potential risk in medical contexts, meeting the criteria for High severity where injury has not yet been reported.

Plain-English summary

Regarding NEURO PACK surgical convenience kits (Item Number 800040012, UDI/DI 10194717112501) manufactured by ROi CPS LLC have been recalled. The kits were distributed containing 3M surgical drapes that are subject to a separate recall.

The affected product was distributed to healthcare facilities in Louisiana, Missouri, North Carolina, and Florida. A total of 69 kits were involved in the distribution.

Affected lot numbers are 91643 (expiration 7/1/2023) and 91242 (expiration 8/12/2023). The recall applies to product code NU00278L.

The recalled product

Product
regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
Manufacturer
ROi CPS LLC
Hazard
  • recalled-component

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)

  • UDI/DI 10194717112501
  • Lot Numbers: 91643
  • exp 7/1/2023
  • 91242
  • exp 8/12/2023

Distribution

Distributed in 4 states:

  • FL
  • LA
  • MO
  • NC