FDA recall Z-1780-2019

Cook Inc. · Class II · device

Product

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.

Distribution

No distribution in the US. Products were distributed to the following foreign countries: China.

Key facts

Status
Terminated
Initiation date
2019-05-02
Report date
2019-06-19
Termination date
2019-08-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1780-2019