The Recall Desk
HighFDA (Devices)·Z-0469-2022·Announced 2022-01-19

Sterilized medical convenience kits recalled for missing latex warning label

ROi CPS LLC is recalling 195 Regard T AND A - Rogers sterilized convenience kits due to missing rubber latex warning labels. Consumers with latex allergies face risk of allergic reaction if exposed to the unlabeled latex.

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 a FDA Class II recall involving missing warning labels for rubber latex, a common allergen. No illnesses or injuries have been reported. Per the severity rubric, allergen mislabeling on common allergens without reported illness is classified as High (3).

Plain-English summary

ROi CPS LLC is recalling 195 Regard T AND A - Rogers sterilized convenience kits because they lack rubber latex warning labels. The recall affects two specific lots: Item Number 8800313004, Lot Number 89090D (UDI 10194717110804, Expiration 07/15/2023) and Item Number 8800313005, Lot Number 89378 (UDI 10194717112730, Expiration 08/05/2023).

The missing warning label creates a risk for individuals with latex allergies who may not be aware of latex content in the kits. Exposure to latex can trigger allergic reactions in affected individuals.

The kits were distributed in Missouri. Consumers in possession of the recalled lots should discontinue use and contact ROi CPS LLC or the FDA for instructions on return or replacement. No illnesses or injuries have been reported at this time.

The recalled product

Product
Regard, T AND A - Rogers, sterilized convenience kits
Manufacturer
ROi CPS LLC
Category
Medical Device — Sterilized Convenience Kits
Hazard
  • missing-warning-label
  • allergen-latex

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) Item Number 8800313004
  • Lot Number 89090D (UDI 10194717110804)
  • Expiration 07/15/2023 2) Item Number 8800313005
  • Lot Number 89378 (UDI 10194717112730)
  • Expiration 08/05/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category