Agency classClass IIOur severity:High FDA (Devices)·Z-2560-2018·Announced 2018-08-08

Galt Medical Recalls Centesis Catheters Due to Bacterial Endotoxin Contamination

Galt Medical Corporation is recalling specific lots of Drainer and Centeze Centesis Catheters because they 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (bacterial endotoxins) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Galt Medical Corporation is recalling 13,210 units of Drainer Centesis Catheters and Centeze Centesis Catheters. The affected products are sterile, ethylene oxide (EO) sterilized, and prescription-only. The recall covers specific catalog numbers and lot numbers for both product lines.

The recall was initiated because the products might contain unsafe levels of bacterial endotoxins, also known as pyrogens, which were introduced during a manufacturing step. Bacterial endotoxins can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

The affected units were distributed in the United States (MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico) and internationally (Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, and Korea). Healthcare providers and patients should check their inventory and patient records for the specific catalog and lot numbers listed in the official recall notice.

The recalled product

Product: 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
Manufacturer: Galt Medical Corporation
Category: Medical Device — Catheters
Hazard: bacterial-endotoxin
pyrogen
Affected units: 13,210

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 (20)

Lot #: 1) a) 18037128
18057123
b) 18026062
18026063
c) 18050076
18092077
2) a) 17303409
17313728
17324971
17324972
17340309
17340310
17355684
b) 17303412
17311642
17335910
17340312
17340314
17355685
17355686

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 8 recalled by Galt Medical Corporation 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 8 products in this recall →

Same manufacturer · Galt Medical Corporation

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Same hazard · bacterial endotoxin