The Recall Desk
HighFDA (Devices)·Z-0411-2022·Announced 2021-12-29

Newborn Kit Needles Recalled Due to Sterility Defect

ROi CPS LLC is recalling regard Clinical Packaging Solutions Newborn Kits (Item 830096005) containing non-sterile needles. The kits were distributed to 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: FDA Class II recall for non-sterile needles, which present risk of infection in vulnerable newborn patients. No illnesses or injuries have been reported; the hazard is recognized but not yet manifested.

Plain-English summary

ROi CPS LLC is recalling regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, which contains two 25GA x .625IN needles. The affected lot is #90074 with expiration date April 17, 2023.

The needles in the kit are non-sterile. Non-sterile needles present a risk of infection, particularly when used in newborn patients.

The kits were distributed to Missouri. A total of 40 kits were affected, with no distribution to foreign, military, or government entities.

The recalled product

Product
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Manufacturer
ROi CPS LLC
Category
Medical Device — Injection Kits
Hazard
  • sterility-defect
  • infection-risk

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 (2)

  • Lot #90074
  • Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.

Distribution

Distribution scope not specified by the agency.

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