Sterile surgical convenience kit: regard recall
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Why was Sterile surgical convenience kit: regard recalled?
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 #95165, exp. 10/27/2024, UDI (01)10194717116387(17)241027(10)95165; lot #95374, exp. 10/17/2024, UDI (01)10194717116387(17)241017(10)95374; and lot #95615, exp. 11/15/2024, UDI (01)10194717116387(17)241115(10)95615.
- Product
- Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
- Recalling firm
- ROi CPS LLC
- Quantity
- 1,312 kits
- Distribution
- US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
- Recall date
- May 3, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)