FDAClass IJune 16, 2021

DeRoyal Angio Cath Removal Tray recall: Labeling Error

DeRoyal Angio Cath Removal Tray, REF 89-9936.02

Why was DeRoyal Angio Cath Removal Tray recalled?

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

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 Numbers: 54368716, exp. 6/01/2022

Product
DeRoyal Angio Cath Removal Tray, REF 89-9936.02
Recalling firm
DeRoyal Industries Inc
Quantity
60 trays
Distribution
US Nationwide distribution to the states of MS, VA, LA, and NY.
Recall date
June 16, 2021
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls