Reported Dec 29, 2021 · Terminated

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

ROi CPS LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758

Is this the product you have?

  • regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Lot codes and dates
  • Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
Amount recalled
40 kits

Where it was sold

Why it was recalled

The kit contains a non-sterile needle.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 7, 2023 · Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.