PlainRecalls
FDA Devices Moderate Class II Terminated

CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

Reported: June 20, 2018 Initiated: May 10, 2018 #Z-2219-2018

Product Description

CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

Reason for Recall

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

Details

Units Affected
27 boxes
Distribution
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.
Location
Glens Falls, NY

Frequently Asked Questions

What product was recalled?
CAN 5F DUAL XCELA PICC, Catalog Number 60M701532. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: 27 boxes.
Why was this product recalled?
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Which agency issued this recall?
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2219-2018.