FDAClass IIJune 8, 2022

I.V. Start Kit recall

I.V. Start Kit Catalog 8172

Why was I.V. Start Kit 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: 2020561 2020560 2020650 2120089 2120018 2120344 2120442 2120645 2120768 2120911 UDI: 00849233015883

Product
I.V. Start Kit Catalog 8172
Recalling firm
Busse Hospital Disposables, Inc.
Quantity
4218 units
Distribution
Nationwide
Recall date
June 8, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls