regard Clinical Packaging Solutions recall: Sterility Concern
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Why was regard Clinical Packaging Solutions recalled?
The kit contains a non-sterile needle.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
- Product
- regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
- Recalling firm
- ROi CPS LLC
- Quantity
- 40 kits
- Distribution
- Distribution was made to Missouri. There was no foreign/military/government distribution.
- Recall date
- December 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)