The Recall Desk
HighFDA (Devices)·Z-0253-2022·Announced 2021-11-24

REGARD Newborn Tray Recalled Due to Out-of-Spec Antiseptic Component

ROi CPS LLC is recalling REGARD Newborn Trays (lot 86453F) distributed in FL, LA, and MO because some units contain a povidone-iodine swabstick component manufactured out of specifications.

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 medical device recall of a critical care component that is out of specifications. Although no illnesses or injuries have been reported, this product is used on newborns and represents a risk-of-harm scenario where injury has not yet been documented.

Plain-English summary

ROi CPS LLC is recalling REGARD Newborn Trays because some units contain a component that fails to meet specifications. The povidone-iodine swabstick, manufactured by PDI, Inc., is out of specifications and may not function as intended.

The recalled product (lot 86453F) was distributed nationwide in Florida, Louisiana, and Missouri. No illnesses or injuries have been reported to date in association with this recall.

The recalled product

Product
REGARD Newborn Tray
Manufacturer
ROi CPS LLC
Category
Medical Device — Newborn Care / Antiseptic Component
Hazard
  • quality-defect
  • out-of-specification

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 (1)

  • Lot number: 86453F

Distribution

Distributed nationwide across the United States.

Related recalls

Same category