FDAClass IIJuly 27, 2022

Nonsterile convenience kit: regard recall: Sterility Concern

Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.

Why was Nonsterile convenience kit: regard recalled?

Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.

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 #92605, exp. 8/31/2023, Item #830014016, UDI #10194717110156.

Product
Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Recalling firm
ROi CPS LLC
Quantity
40 kits
Distribution
Distribution was made to MO. There was no foreign/military/government distribution.
Recall date
July 27, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls