FDAClass IINovember 20, 2024

Halyard IR ABCESS DRAINAGE PACK - Medical convenience recall: Foreign Material

Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018

Why was Halyard IR ABCESS DRAINAGE PACK - Medical convenience recalled?

Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions

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?

GTIN: 10809160304952 Lot Number: 1600756

Product
Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018
Recalling firm
AVID Medical, Inc.
Quantity
80 eaches
Distribution
US Nationwide distribution.
Recall date
November 20, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls