Z-2205-2018 Class II Terminated

Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) — Glens Falls, NY

Recall Details

Product Type
Devices
Report Date
June 20, 2018
Initiation Date
May 10, 2018
Termination Date
May 13, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 boxes

Product Description

RS 5F DL BIOFLO PASV, Catalog Number 60M132324

Reason for Recall

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Distribution Pattern

The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.

Code Information

UPN: H96560M1323241; Lot: 5312922