Agency classClass IIOur severity:Severe FDA (Devices)·Z-2212-2018·Announced 2018-06-20

Angiodynamics Recalls RS Tandem 5F DL Xcela PICC Catheters

Angiodynamics Inc. is recalling 13 boxes of RS Tandem 5F DL Xcela PICC catheters 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the presence of unsafe bacterial endotoxins in a medical device constitutes a significant health risk warranting a Severe rating under the Class II criteria.

Plain-English summary

Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 13 boxes of RS Tandem 5F DL Xcela PICC catheters, Catalog Number 60M181582. The recall was initiated because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

The affected products were distributed to 34 US states, including Arizona, California, and New York, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5299859, and the Universal Product Number (UPN) is H96560M1815821.

Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on how to return or dispose of the products. Patients who have received these catheters should consult their healthcare provider if they experience any adverse symptoms.

The recalled product

Product: RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)
Category: Medical Device — Catheters
Hazard: bacterial-endotoxin
Affected units: 13

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 (2)

UPN: H96560M1815821
Lot: 5299859

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