FDAClass IIJune 19, 2019

Neff Percutaneous Access Set recall: Sterility Concern

Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

Why was Neff Percutaneous Access Set recalled?

The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.

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 8373482

Product
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Recalling firm
Cook Inc.
Quantity
97
Distribution
No distribution in the US. Products were distributed to the following foreign countries: China.
Recall date
June 19, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls