FDAClass IIOctober 7, 2020

KIT, PRE OP DRAH - Product Usage: Preoperative kit used recall

KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.

Why was KIT, PRE OP DRAH - Product Usage: Preoperative kit used recalled?

Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.

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?

Model: ORPDH5994A Lot numbers: 558357, 561502,566549, 571467, 574058. Expiration dates: Varies by kit components.

Product
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Recalling firm
Cardinal Health 200, LLC
Quantity
9,150 kits
Distribution
US Nationwide distribution including the state of North Carolina.
Recall date
October 7, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls