Recall Z-0411-2022— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2021-11-04, terminated 2023-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.. Reason: The kit contains a non-sterile needle..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-04
- Terminated
- 2023-08-07
- Firm location
- Republic, MO, United States
Product description
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Reason for recall
The kit contains a non-sterile needle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.