Agency classClass IIOur severity:Severe FDA (Devices)·Z-2218-2018·Announced 2018-06-20

Angiodynamics Recalls XCELA PICC Kits Due to Bacterial Endotoxins

Angiodynamics Inc. is recalling 17 boxes of CAN 5F SINGLE XCELA PICC kits because a component may contain unsafe levels of bacterial endotoxins.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the presence of unsafe levels of bacterial endotoxins in a medical device poses a risk of significant injury, meeting the criteria for a Severe rating.

Plain-English summary

Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 17 boxes of CAN 5F SINGLE XCELA PICC kits, Catalog Number 60M701531. The recall was initiated because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

The affected products were distributed to 33 U.S. states, the District of Columbia, and four foreign countries: Canada, China, Ireland, and Spain. The specific U.S. states include 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.

Healthcare providers and consumers should check their inventory for the specific lot numbers 5299826 and 5312185, or the UPN H96560M7015311. If these products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Category: Medical Device — PICC Line
Hazard: bacterial-endotoxin
Affected units: 17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

UPN: H96560M7015311
Lot: 5299826
5312185

Distribution

Distributed in 34 states:

Part of a larger recall action

This product is one of 38 recalled by Angiodynamics Inc. (Navilyst Medical Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 38 products in this recall →

Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)

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Same hazard · bacterial endotoxin