FDAClass IIJune 20, 2018

CAN 5f Dual Xcela Picc recall: Endotoxin

CAN 5F DUAL XCELA PICC, Catalog Number 60M701532

Why was CAN 5f Dual Xcela Picc recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UPN: H96560M7015321; Lot: 5300582, 5312582

Product
CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
Recalling firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Quantity
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.
Recall date
June 20, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls