FDAClass IIJune 8, 2022

I.V. Start Kit - Tegaderm Dressing - Catheter recall

I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822

Why was I.V. Start Kit - Tegaderm Dressing - Catheter recalled?

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

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: 2020514 2020525 2020734 2120255 2120304 2120325 2120439 UDI: 00849233010017

Product
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Recalling firm
Busse Hospital Disposables, Inc.
Quantity
2475
Distribution
Nationwide
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls