Z-1780-2019Class II

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

Name: Z-1780-2019 Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Creator: Cook Inc.
Published: 2019-05-02
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-05-02 / Terminated / root cause: packaging

FDA source

Cook Inc. began a recall of Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT on 2019-05-02. FDA classified it as Class II and gives the reason as "The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1780-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Posted: 2019-06-13
Terminated: 2019-08-23
Recalling firm: Cook Incorporated
Product: Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Product code: KGZ Accessories, Catheter
Reason for recall: The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall notification letters dated 5/2/19 were sent to customers.
Quantity in commerce: 97
Distribution: No distribution in the US. Products were distributed to the following foreign countries: China.
Product codes and lots: lot 8373482

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1780-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1780-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-19	2019-06-13

Product code KGZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)