Recall Z-1780-2019— Cook Inc.

Name: FDA recall Z-1780-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-02

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2019-05-02, terminated 2019-08-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT. Reason: The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-05-02
Terminated: 2019-08-23
Firm location: Bloomington, IN, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.