FDAClass IIIApril 6, 2022

Regard Custom Procedure Kits containing BD Luer Lok recall

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

Why was Regard Custom Procedure Kits containing BD Luer Lok recalled?

Recalled devices were packaged in convenience 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?

IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022)

Product
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Recalling firm
ROi CPS LLC
Quantity
1750 kits
Distribution
US Nationwide distribution in the state of Missouri.
Recall date
April 6, 2022
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls