Use caution Medical device recall · FDA · Published May 2, 2018

Galt Medical Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins Risk

Galt Medical recalls specific Drainer Centesis Catheters (catalog numbers DRC-001-05 to DRC-001-15 and DRC-002-02 to DRC-002-08) due to potential unsafe bacterial endotoxin levels that could cause fever, chills, and low blood pressure.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2560-2018Medical device Galt Medical ›

Use caution until it’s fixed

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

Take action

Contact the company

Recalling firmGalt Medical Corporation2220 Merritt Dr · Garland, TX 75041-6137

✎ GovInfoNow plain-language explainer

Galt Medical is recalling certain Drainer Centesis Catheters because they may contain unsafe levels of bacterial endotoxins. This could lead to fever, chills, and low blood pressure in patients using the catheters. Read more at govinfonow.com/recall/71213-galt-medical-recalls-drainer-centesis-catheters-due-to-bacterial-endotoxins.

Source Summary by GovInfoNow · govinfonow.com/recall/71213-galt-medical-recalls-drainer-centesis-catheters-due-to-bacterial-endotoxins · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2560-2018

Cite this page

“Galt Medical Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71213-galt-medical-recalls-drainer-centesis-catheters-due-to-bacterial-endotoxins. Based on FDA recall #Z-2560-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2560-2018%22&limit=1).

The FDA announced on May 2, 2018, that Galt Medical Corporation voluntarily recalled Drainer Centesis and Centeze catheters due to potential unsafe levels of bacterial endotoxins. The agency stated the devices could cause fever, chills, or hypotension in patients.

How to tell if you have it

Brand: Galt Medical
Product: Drainer Centesis Catheter, Sterile EO, Rx Only (Catalog #: DRC-001-05, DRC-001-06, DRC-001-15)
Product: Centeze Centesis Catheter, Sterile EO, Rx Only (Catalog #: DRC-002-02, DRC-002-05, DRC-002-06, DRC-002-08)
Lot codes include 18037128, 18057123, 18026062, 18026063, 18050076, 18092077, 17303409, 17313728, 17324971, 17324972, 17340309, 17340310, 17355684, 17303412, 17311642, 17335910, 17340312, 17340314, 17355685, 17355686, 17355687, 17311643, 17314335, 17349257, 18026356, 18033604, 18047978, 18096513, 18110747, 17314337, 17321338, 17352567, 18005181
Units affected: 13,210

The hazard

The FDA said the catheters might contain unsafe levels of bacterial endotoxins introduced during manufacturing. These pyrogens can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

Context

GovInfoNow's records show Galt Medical Corporation has 4 other recalls on record since 2020-11-16. Other recent recalls of similar products include Getinge Thoracic Catheter Recall (2026-08-07), Codman CerebroFlo EVD Catheter Recall (2026-04-10), and Medline ReNewal Reprocessed Webster CS Catheters Recall (2025-12-22).

How to tell if you have this one

Check for catalog numbers DRC-001-05, DRC-001-06, DRC-001-15, DRC-002-02, DRC-002-05, DRC-002-06, or DRC-002-08. Also look for specific production lots listed in the recall notice.

Brand
Galt Medical
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea

Recall number	Product, codes & lots	Quantity
Z-2558-2018	1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;; Lot #: 1) a) S18015025; b) S18015026, c) S18015027; d) S18046198; 2) a) G17356364; 3) a) S18016057, S18106396, b) S18080265 4) a) S18032092, S18032093, S18032094; b) S18046163;	3160
Z-2559-2018	1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;; lot #: 1) 18102478; 2) 18033450; 3) a) 18089973; b) 18031311; c) 18046318; d) 18082001; e) 18040777, 18061334; 4) S17342075; 5) P18015009; 6) S18051159, S18072306; 7) S18072307; 8) a) S18033049, S18064105, S18093202, S18096316; b) S18025037, S18032055, S18032100, S18032101, S18093199, S18096314; c) S18093200; d) S18032056, S18032102, S18052063, S18074161, S18093203, S18096318; e) S18064104, S18093201; f) S18096315; 9) S18018008; 10) a) G18012001, G18064125; b) S18017001	9050
Z-2560-2018	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,; 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, 17355687; c) 17311643, 17314335, 17349257, 18026356, 18033604, 18047978, 18096513, 18110747; d) 17314337, 17321338, 17352567, 18005181	13210
Z-2561-2018	1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03; Lot #: 1) a) G18046082, G18046083, G18046084, G18046085; b) G18031106, G18031199, G18046076; c) G18030048, G18030049; d) G18030050, G18030204; 2) a) G18003035, G18101170; b) G18003036, G18003037, G18003038	8350
Z-2562-2018	Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055; Lot #: a) 18032057, 18032058; b) 18001013, 18046016, 18162838; c) 18019455 18019456, 18019457, 18019458, 18019460, 18047461, 18047462, 18047463; d) 17363374, 18116090	10950
Z-2563-2018	Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,; Lot #: a) 18043101; b) 18124426, 18120765	300
Z-2564-2018	TVS LPA, Catalog #: DIL-059-00; Lot #: 17338821, 18019045	3530
Z-2565-2018	Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46; Lot #: a) 18024880, 18043086, 18066833, 18073282; b) 18039555, 18059249, 18074835; c) 17363134; d) 17352818, 18051601; e) 18019228, 18047509; f) 18023833; g) 17356436, 18018694, 18018695, 18040074; h) 18061579; i) 18015027; j) 18019038, 18029067, 18033068, 18075816, 18075817, 18075818; k) 17363816, 18023834, 18026040, 18026072, 18033073, 18033079, 18054248; l) 18005018, 18012032, 18012034, 18012035, 18012036, 18019037, 18026953, 18089355, 18096357, 18096358, 18103359; m) 18047202; n) 18054349	23777

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the catalog numbers and production lots listed in the recall notice to confirm if your catheter is affected.

Where it went and when

Where it was distributed

Distributed in 18 states and Puerto Rico, and outside the U.S.

FDA distribution: “U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

May 2, 2018Firm started the recall
Jul 27, 2018FDA classified it Class II
Aug 8, 2018Published in FDA’s Enforcement Report
Jul 20, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any specific production lots that are affected?

Yes, specific production lots are listed in the recall notice, including numbers like 18037128, 18057123, and others.

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Link to this recall

<a href="https://govinfonow.com/recall/71213-galt-medical-recalls-drainer-centesis-catheters-due-to-bacterial-endotoxins">Galt Medical Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2560-2018 (May 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2560-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.