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.
What this means for you
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
- 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
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.
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